A Phase 1/2 interventional study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm and Myeloproliferative Neoplasm, sponsored by AbbVie. Active, not recruiting at 29 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by AbbVie · Phase 1/2, Interventional, and Treatment
This is an open-label, multi-center, Phase 1/2 study to determine the MTD and assess the safety, tolerability, PK, immunogenicity, and anti-leukemia activity of IMGN632 when administered as monotherapy to patients with CD123+ disease.
IMGN632 is administered by IV on Day 1 of each cycle, with cycles repeating every 21 days.
45 studies on the registry are indexed under Blastic Plasmacytoid Dendritic Cell Neoplasm; 15 are open to participants now.
This study's enrollment of 179 is above the median of 40 across 37 interventional studies indexed under Blastic Plasmacytoid Dendritic Cell Neoplasm.
Browse Blastic Plasmacytoid Dendritic Cell Neoplasm studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Disease Characteristics:
a. Confirmation of CD123 positivity by flow cytometry or IHC. Participants who received prior CD123-targeting agents will be allowed as long as the blasts still have detectable CD123 expression.
Expansion inclusion:
Note: Participants in Cohort 6 may have received local therapy (radiotherapy, surgical excision, photodynamic therapy). Eligible participants must have a recurrence or progression in the field of local therapy OR disease outside the field of local therapy.
Exclusion Criteria:
Note: the exception that participants who have received a must not have received that therapy within 28 days prior to drug administration on this study.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Escalation: IMGN632 was administered by IV on 2 different schedules for participants with relapsed/refractory AML, ALL, or BPDCN. Expansion: IMGN632 was administered by IV: * Cohort 1: Relapsed or refractory BPDCN participants who have received 1-3 prior systemic therapies (incl. tagraxofusp-erzs and/or any other systemic therapy deemed appropriate for the treatment of BPDCN) * Cohort 2: Relapsed AML * Cohort 3: Relapsed or refractory ALL * Cohort 4: Other relapsed or refractory hematologic malignancies * Cohort 5: Relapsed or refractory AML at alternate dose or schedule * Cohort 6: Pivotal cohort for frontline BPDCN participants who have not received prior systemic therapy and participants with frontline BPDCN who have prior or concomitant hematologic malignancy (PCHM) and have not received prior systemic therapy.
Drug: IMGN632
CD123-targeted ADC
Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
Time frame: Up to approximately 81 months
Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs)
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to approximately 81 months
Maximum Plasma Concentration (Cmax) of IMGN632 (Antibody Drug Conjugate [ADC]) and Total Antibody
Time frame: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Cmax of FGN849
Time frame: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Area Under the Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) of IMGN632 (ADC) and Total Antibody
Time frame: Cycle 1 and Cycle 3 (each cycle length = 21 days)
AUC0-last of FGN849
Time frame: Cycle 1 and Cycle 3 (each cycle length = 21 days)
Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit
Time frame: Up to approximately 81 months
Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML
ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL. MLFS: Bone marrow \<5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
Time frame: Up to approximately 81 months
Dose Escalation Phase: CR+CRh Rate, As Assessed by Investigator in Participants With AML
CR+CRh rate was defined as percentage of participants with CR, and CRh. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL.
Time frame: Up to approximately 81 months
Dose Escalation Phase: CR+CRh+CRi Rate, As Assessed by Investigator in Participants With AML
CR+CRh+CRi rate was defined as percentage of participants with CR, CRh, or CRi. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL.
Time frame: Up to approximately 81 months
CCR Rate As Assessed by Investigator in Participants With Relapsed/Refractory (R/R) BPDCN
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
Duration of CCR (DOCR) As Assessed by Investigator in Frontline De Novo BPDCN Participants With CR or CRc
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever came first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. Median and 95% CI were calculated by Kaplan-Meier estimation.
Time frame: Up to approximately 81 months
DOCR As Assessed by Investigator in R/R BPDCN Participants With CR or CRc
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg)
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Up to approximately 81 months
Rate of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
Rate of CR+CRc+CRh: percentage of participants with CR, CRc, and CRh. CR: normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Time frame: Up to approximately 81 months
Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants
Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
Time frame: Up to approximately 81 months
ORR As Assessed by Investigator in Total R/R BPDCN Participants
ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by \> 50% in blast percentage to 5%-25%; 50% to \<100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
Time frame: Up to approximately 81 months
Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants
Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.
Time frame: Up to approximately 81 months
Overall Survival in Total R/R BPDCN Participants
Overall survival was defined as date of first dose until death from any cause.
Time frame: Up to approximately 81 months
CCR Rate As Assessed by Investigator in All Frontline BPDCN Participants With Post-Treatment Consolidative Stem Cell Transplant (SCT)
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
Time frame: Up to approximately 81 months
Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants
Post-baseline transfusion independence (red blood cell \[RBC\] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.
Time frame: Up to approximately 81 months
| Milestone | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 3 | 12 | 13 | 7 | 5 | 2 | 3 | 6 | 14 | 104 | 10 |
| Received at least 1 dose of study drug | 3 | 12 | 13 | 7 | 5 | 2 | 3 | 6 | 14 | 104 | 10 |
| Completed | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 0 |
| Not completed | 3 | 11 | 12 | 7 | 5 | 2 | 3 | 6 | 14 | 96 | 10 |
| Withdrew: Withdrawal by subject | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 1 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 |
| Withdrew: Sponsor decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Investigator decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Death | 2 | 10 | 12 | 7 | 5 | 2 | 3 | 6 | 12 | 76 | 9 |
| Withdrew: Other than specified | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Withdrew: Ongoing in trial at time of data cutoff | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 0 |
CCR rate was defined as percentage of participants with complete remission/response (CR) and clinical complete remission (CRc). CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/microliter \[μL\]) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on computed tomography (CT); and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| percentage of participants | Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Composite Complete Remission/Response (CCR) Rate As Assessed by Investigator in Frontline De Novo Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) Participants | 72.7 (49.78 to 89.27) |
An adverse event (AE) was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. SAEs included death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as any new AEs that begin or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.
| Participants | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| All TEAEs | 3 | 12 | 13 | 7 | 5 | 2 | 3 | 6 | 14 |
| SAEs | 2 | 7 | 11 | 7 | 5 | 2 | 2 | 6 | 11 |
DLT was defined as all treatment-emergent adverse events (TEAEs) or abnormal laboratory values that met the protocol-defined DLT criteria, including those TEAEs and abnormal laboratory values that resulted in a failure to meet the criteria for re-treatment. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 |
| micrograms (µg)/milliliter (mL) | Schedule A: IMGN632 0.015 mg/kg | Schedule A: IMGN632 0.045 mg/kg | Schedule A: IMGN632 0.09 mg/kg | Schedule A: IMGN632 0.18 mg/kg | Schedule A: IMGN632 0.3 mg/kg | Schedule A: IMGN632 0.45 mg/kg | Schedule B: IMGN632 0.015 mg/kg | Schedule B: IMGN632 0.03 mg/kg | Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| IMGN632 ADC: Cycle 1 | 0.0291 ± 669 | 0.442 ± 122 | 1.08 ± 68 | 2.69 ± 26 | 4.64 ± 42 | 8.44 ± 21 | 0.0247 ± 72 | 0.396 ± 234 | 0.405 ± 120 |
| Total Antibody: Cycle 1 | 0.160 ± NA | 0.611 ± 143 | 0.978 ± 105 | 2.79 ± 37 | 4.87 ± 45 | 7.36 ± 21 | — | 0.439 ± 256 | 0.415 ± 108 |
| IMGN632 ADC: Cycle 3 | 0.0789 ± NA | 0.564 ± 105 | 2.08 ± 127 | — | — | — | 0.0291 ± 1831 | 0.480 ± 43 | — |
| Total Antibody: Cycle 3 | — | 0.607 ± 81 | 2.03 ± 146 | — | — | — | 0.167 ± NA | 0.457 ± 28 | — |
| picograms (pg)/mL | Schedule A: IMGN632 0.015 mg/kg | Schedule A: IMGN632 0.045 mg/kg | Schedule A: IMGN632 0.09 mg/kg | Schedule A: IMGN632 0.18 mg/kg | Schedule A: IMGN632 0.3 mg/kg | Schedule A: IMGN632 0.45 mg/kg | Schedule B: IMGN632 0.015 mg/kg | Schedule B: IMGN632 0.03 mg/kg | Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 | — | 58.8 ± 77 | 79.7 ± 80 | 65.4 ± 25 | 152 ± 67 | 102 ± 70 | — | 36.0 ± 33 | 55.7 ± 90 |
| Cycle 3 | — | 43.7 ± 55 | 28.7 ± 51 | — | — | — | — | 27.1 ± 37 | — |
| hours*µg/mL | Schedule A: IMGN632 0.015 mg/kg | Schedule A: IMGN632 0.045 mg/kg | Schedule A: IMGN632 0.09 mg/kg | Schedule A: IMGN632 0.18 mg/kg | Schedule A: IMGN632 0.3 mg/kg | Schedule A: IMGN632 0.45 mg/kg | Schedule B: IMGN632 0.015 mg/kg | Schedule B: IMGN632 0.03 mg/kg | Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| IMGN632 ADC: Cycle 1 | 0.0471 ± 825 | 0.892 ± 223 | 4.12 ± 140 | 24.7 ± 44 | 46.7 ± 66 | 113 ± 42 | 0.0227 ± 31 | 0.792 ± 248 | 1.11 ± 269 |
| Total Antibody: Cycle 1 | 0.152 ± NA | 0.939 ± 241 | 3.50 ± 254 | 31.0 ± 66 | 51.8 ± 68 | 123 ± 50 | — | 0.708 ± 355 | 1.02 ± 371 |
| IMGN632 ADC: Cycle 3 | 0.202 ± NA | 1.61 ± 191 | 12.1 ± 56 | — | — | — | 0.0145 ± 1831 | 1.25 ± 185 | — |
| Total Antibody: Cycle 3 | — | 1.41 ± 124 | 15.4 ± 111 | — | — | — | 0.0835 ± NA | 1.05 ± 121 | — |
| hours*pg/mL | Schedule A: IMGN632 0.015 mg/kg | Schedule A: IMGN632 0.045 mg/kg | Schedule A: IMGN632 0.09 mg/kg | Schedule A: IMGN632 0.18 mg/kg | Schedule A: IMGN632 0.3 mg/kg | Schedule A: IMGN632 0.45 mg/kg | Schedule B: IMGN632 0.015 mg/kg | Schedule B: IMGN632 0.03 mg/kg | Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Cycle 1 | — | 171 ± 116 | 354 ± 99 | 248 ± 41 | 1260 ± 73 | 1139 ± 29 | — | 63.5 ± 158 | 177 ± 169 |
| Cycle 3 | — | 125 ± 105 | 59.6 ± 1541 | — | — | — | — | 66.1 ± 144 | — |
| Participants | Schedule A: IMGN632 0.015 mg/kg | Schedule A: IMGN632 0.045 mg/kg | Schedule A: IMGN632 0.09 mg/kg | Schedule A: IMGN632 0.18 mg/kg | Schedule A: IMGN632 0.3 mg/kg | Schedule A: IMGN632 0.45 mg/kg | Schedule B: IMGN632 0.015 mg/kg | Schedule B: IMGN632 0.03 mg/kg | Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Anti-drug Antibodies (ADAs) at Any Post-baseline Visit | 1 | 22 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
ORR was defined as percentage of participants with CR without minimal residual disease (CRMRD-), CR, CR with partial hematologic recovery (CRh), CR with incomplete recovery (CRi), morphologic leukemia-free state (MLFS), or partial response (PR). CRMRD-: CR with negativity for a genetic marker. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL. MLFS: Bone marrow \<5% blasts in an aspirate with spicules; No blasts with Auer rods or persistence of extramedullary disease; Marrow not "aplastic"; ≥200 cells should be enumerated or cellularity should be ≥10%. PR: Decrease of ≥50% in percentage of blasts to 5% to 25% in bone marrow aspirate (BMA) and normalization of blood counts.
| percentage of participants | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase: Overall Response Rate (ORR), As Assessed by Investigator in Participants With AML | 33.3 (0.84 to 90.57) | 22.2 (2.81 to 60.01) | 8.3 (0.21 to 38.48) | 14.3 (0.36 to 57.87) | 20.0 (0.51 to 71.64) | 0 (0.0 to 84.19) | 0 (0.00 to 70.76) | 16.7 (0.42 to 64.12) | 7.1 (0.18 to 33.87) |
CR+CRh rate was defined as percentage of participants with CR, and CRh. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL.
| percentage of participants | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase: CR+CRh Rate, As Assessed by Investigator in Participants With AML | 33.3 (0.84 to 90.57) | 11.1 (0.28 to 48.25) | 0 (0.00 to 26.46) | 14.3 (0.36 to 57.87) | 0 (0.00 to 52.18) | 0 (0.00 to 84.19) | 0 (0.00 to 70.76) | 0 (0.00 to 45.93) | 0 (0.00 to 23.16) |
CR+CRh+CRi rate was defined as percentage of participants with CR, CRh, or CRi. CR: Morphologic CR \<5% blasts; Absolute neutrophil count (ANC) \>1000/μL; Platelets ≥100,000/μL; Participant independent of transfusions; No residual evidence of active extramedullary disease; MRD+ or unknown. CRh: Met requirements for CR except ANC \>500/μL and platelets \>50,000/μL. CRi: Met requirements for CR except either ANC \<1000/μL or platelets \<100,000/μL.
| percentage of participants | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg |
|---|---|---|---|---|---|---|---|---|---|
| Dose Escalation Phase: CR+CRh+CRi Rate, As Assessed by Investigator in Participants With AML | 33.3 (0.84 to 90.57) | 11.1 (0.28 to 48.25) | 0 (0.00 to 26.46) | 14.3 (0.36 to 57.87) | 20.0 (0.51 to 71.64) | 0 (0.00 to 84.19) | 0 (0.00 to 70.76) | 16.7 (0.42 to 64.12) | 7.1 (0.18 to 33.87) |
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| percentage of participants | BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| CCR Rate As Assessed by Investigator in Participants With Relapsed/Refractory (R/R) BPDCN | 13.7 (5.70 to 26.26) |
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever came first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. Median and 95% CI were calculated by Kaplan-Meier estimation.
| months | Frontline De Novo BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Duration of CCR (DOCR) As Assessed by Investigator in Frontline De Novo BPDCN Participants With CR or CRc | 10.18 (4.402 to NA) |
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| months | R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| DOCR As Assessed by Investigator in R/R BPDCN Participants With CR or CRc | 9.20 (2.398 to NA) |
DOCR was defined from the first response (CR or CRc) to the time of relapse or death from any cause, whichever comes first. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| months | Total Frontline BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| DOCR As Assessed by Investigator in Total Frontline BPDCN Participants With CR or CRc | 9.76 (4.632 to NA) |
An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included an exacerbation of a pre-existing condition. TEAEs were defined as any new AEs that began or any pre-existing conditions that worsen in severity from the first dose of study drug through 30 days after the last dose or prior to the subsequent therapy, whichever occurs first.. A summary of all SAEs and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
| Participants | Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Number of Participants With TEAEs in Participants Who Received IMGN632 As a Single Agent at the RP2D Level (0.045 mg/kg) | 115 |
Rate of CR+CRc+CRh: percentage of participants with CR, CRc, and CRh. CR: normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
| percentage of participants | Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Rate of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants | 17.6 (8.40 to 30.87) |
Duration of CR+CRc+CRh was defined as time from first response to time of relapse or death from any cause, whichever came first. CR: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) and platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRh: normalization of neutrophil count (≥ 500/μL) and platelet count (≥ 50,000/μL); other criteria same as defined for CRc.
| months | Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Duration of CR+CRc+CRh As Assessed by Investigator in Total R/R BPDCN Participants | 9.20 (0.789 to NA) |
ORR: percentage of participants with CR, CRc, CRh, CRi, and PR. CR, CRc, and CRh as defined in Outcome Measure 20 above. CRi: normalization of blast percentage (≤5%); normalization of neutrophil count (≥1000/μL) or platelet count (≥100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. PR: Decreased by \> 50% in blast percentage to 5%-25%; 50% to \<100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; ≥50% decrease in the sum of the product of the diameters (SPD) of up to 6 largest dominant masses, no increase in size of other nodes; ≥ 50% decrease in SPD of nodules (for single nodule in greatest transverse diameter), no increase in size of liver of spleen.
| percentage of participants | Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| ORR As Assessed by Investigator in Total R/R BPDCN Participants | 35.3 (22.43 to 49.93) |
Duration of overall response (CR, CRc, CRh, CRi, and PR) was defined as time from first response to time of relapse or death from any cause, whichever came first. CR, CRc, and CRh, CRi, and PR as defined in Outcome Measure 21 above.
| months | Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Duration of Overall Response As Assessed by Investigator in Total R/R BPDCN Participants | 4.14 (1.807 to NA) |
Overall survival was defined as date of first dose until death from any cause.
| months | Total R/R BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Overall Survival in Total R/R BPDCN Participants | 5.78 (3.943 to 8.378) |
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| percentage of participants | Frontline BPDCN Participants With Post-Treatment Consolidative SCT - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| CCR Rate As Assessed by Investigator in All Frontline BPDCN Participants With Post-Treatment Consolidative Stem Cell Transplant (SCT) | 92.3 (63.97 to 99.81) |
CCR rate was defined as percentage of participants with CR and CRc. CR was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; 100% clearance of all skin lesions from baseline; no new lesions in participants without lesions at baseline; nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared. CRc was defined as normalization of blast percentage (≤ 5%); normalization of neutrophil count (≥ 1000/μL) and platelet count (≥ 100,000/μL); absence of leukemic blasts; marked clearance of all skin lesions from baseline, residual hyperpigmentation or abnormality with BPDCN identified on biopsy (or no biopsy performed); nodal masses regression to normal size on CT; and spleen and liver not palpable and nodules disappeared.
| percentage of participants | All R/R BPDCN Participants With Post-Treatment Consolidative SCT - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| CCR Rate As Assessed by Investigator in All R/R BPDCN Participants With Post-Treatment Consolidative SCT | 33.3 (4.33 to 77.72) |
Post-baseline transfusion independence (red blood cell \[RBC\] and platelet transfusion independence) was defined as any 56-day period after Cycle 1 Day 1 in which the participant did not receive either a RBC or platelet transfusion.
| percentage of participants | BPDCN Participants - Schedule A: IMGN632 0.045 mg/kg |
|---|---|
| Percentage of Participants With Post-baseline Transfusion Independence in BPDCN Participants | 63.1 (51.87 to 73.37) |
Collected over Up to approximately 81 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | 2/3 (66.7%) | 2/3 (66.7%) | 3/3 (100%) |
| Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | 10/12 (83.3%) | 8/12 (66.7%) | 12/12 (100%) |
| Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | 12/13 (92.3%) | 11/13 (84.6%) | 13/13 (100%) |
| Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | 7/7 (100%) | 7/7 (100%) | 7/7 (100%) |
| Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | 5/5 (100%) | 5/5 (100%) | 5/5 (100%) |
| Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | 2/2 (100%) | 2/2 (100%) | 2/2 (100%) |
| Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | 3/3 (100%) | 2/3 (66.7%) | 3/3 (100%) |
| Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | 6/6 (100%) | 6/6 (100%) | 5/6 (83.3%) |
| Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | 12/14 (85.7%) | 12/14 (85.7%) | 12/14 (85.7%) |
| Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | 76/104 (73.1%) | 66/104 (63.5%) | 102/104 (98.1%) |
| Dose Expansion - Schedule A: IMGN632 0.09 mg/kg | 9/10 (90%) | 10/10 (100%) | 10/10 (100%) |
| Event | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| PNEUMONIAINFECTIONS AND INFESTATIONS | 2/3 | 3/12 | 5/13 | 3/7 | 2/5 | 0/2 | 1/3 | 3/6 | 4/14 | 11/104 | 1/10 |
| FEBRILE NEUTROPENIABLOOD AND LYMPHATIC SYSTEM DISORDERS | 1/3 | 1/12 | 4/13 | 2/7 | 2/5 | 1/2 | 0/3 | 0/6 | 1/14 | 13/104 | 1/10 |
| SOFT TISSUE INFECTIONINFECTIONS AND INFESTATIONS | 0/3 | 0/12 | 0/13 | 0/7 | 0/5 | 1/2 | 0/3 | 1/6 | 0/14 | 0/104 | 0/10 |
| URINARY TRACT INFECTIONINFECTIONS AND INFESTATIONS | 0/3 | 0/12 | 1/13 | 1/7 | 0/5 | 1/2 | 1/3 | 0/6 | 0/14 | 0/104 | 0/10 |
| VENOOCCLUSIVE DISEASEVASCULAR DISORDERS | 0/3 | 0/12 | 0/13 | 0/7 | 0/5 | 1/2 | 0/3 | 0/6 | 1/14 | 4/104 | 0/10 |
| SEPSISINFECTIONS AND INFESTATIONS | 0/3 | 2/12 | 1/13 | 1/7 | 2/5 | 0/2 | 0/3 | 1/6 | 2/14 | 7/104 | 1/10 |
| LOWER GASTROINTESTINAL HAEMORRHAGEGASTROINTESTINAL DISORDERS | 1/3 | 0/12 | 0/13 | 0/7 | 0/5 | 0/2 | 0/3 | 0/6 | 0/14 | 0/104 | 0/10 |
| RECTAL HAEMORRHAGEGASTROINTESTINAL DISORDERS | 1/3 | 0/12 | 0/13 | 0/7 | 1/5 | 0/2 | 0/3 | 0/6 | 0/14 | 1/104 | 1/10 |
| FATIGUEGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 1/3 | 0/12 | 0/13 | 0/7 | 1/5 | 0/2 | 0/3 | 0/6 | 2/14 | 2/104 | 0/10 |
| LOCALISED OEDEMAGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 1/3 | 0/12 | 0/13 | 0/7 | 0/5 | 0/2 | 0/3 | 0/6 | 0/14 | 0/104 | 0/10 |
| Event | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CONSTIPATIONGASTROINTESTINAL DISORDERS | 1/3 | 3/12 | 3/13 | 1/7 | 3/5 | 2/2 | 0/3 | 1/6 | 5/14 | 25/104 | 0/10 |
| OEDEMA PERIPHERALGENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS | 2/3 | 2/12 | 3/13 | 1/7 | 2/5 | 2/2 | 1/3 | 3/6 | 3/14 | 49/104 | 4/10 |
| DECREASED APPETITEMETABOLISM AND NUTRITION DISORDERS | 3/3 | 1/12 | 2/13 | 1/7 | 2/5 | 1/2 | 2/3 | 0/6 | 2/14 | 16/104 | 1/10 |
| HYPERGLYCAEMIAMETABOLISM AND NUTRITION DISORDERS | 0/3 | 0/12 | 2/13 | 1/7 | 0/5 | 0/2 | 3/3 | 1/6 | 1/14 | 15/104 | 2/10 |
| HEADACHENERVOUS SYSTEM DISORDERS | 1/3 | 1/12 | 2/13 | 0/7 | 1/5 | 2/2 | 0/3 | 0/6 | 1/14 | 18/104 | 0/10 |
| ANAEMIABLOOD AND LYMPHATIC SYSTEM DISORDERS | 0/3 | 3/12 | 0/13 | 1/7 | 0/5 | 0/2 | 2/3 | 0/6 | 1/14 | 22/104 | 3/10 |
| SINUS TACHYCARDIACARDIAC DISORDERS | 2/3 | 0/12 | 1/13 | 1/7 | 0/5 | 0/2 | 0/3 | 1/6 | 0/14 | 5/104 | 0/10 |
| DIARRHOEAGASTROINTESTINAL DISORDERS | 2/3 | 5/12 | 8/13 | 3/7 | 2/5 | 1/2 | 1/3 | 0/6 | 3/14 | 22/104 | 3/10 |
| NAUSEAGASTROINTESTINAL DISORDERS | 1/3 | 4/12 | 7/13 | 2/7 | 1/5 | 1/2 | 2/3 | 1/6 | 7/14 | 22/104 | 1/10 |
| STOMATITISGASTROINTESTINAL DISORDERS | 0/3 | 2/12 | 2/13 | 2/7 | 0/5 | 0/2 | 2/3 | 0/6 | 0/14 | 7/104 | 0/10 |
The safety population included all participants who received at least 1 dose of study drug.
| Age, Categorical(Participants) | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 8 | 4 | 0 | 0 | 1 | 0 | 4 | 34 | 4 | 58 |
| >=65 years | 2 | 10 | 5 | 3 | 5 | 2 | 2 | 6 | 10 | 70 | 6 | 121 |
| Sex: Female, Male(Participants) | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 2 | 8 | 8 | 3 | 2 | 1 | 1 | 4 | 3 | 17 | 4 | 53 |
| Male | 1 | 4 | 5 | 4 | 3 | 1 | 2 | 2 | 11 | 87 | 6 | 126 |
| Ethnicity (NIH/OMB)(Participants) | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 13 | 2 | 19 |
| Not Hispanic or Latino | 3 | 9 | 12 | 6 | 5 | 2 | 2 | 5 | 14 | 85 | 8 | 151 |
| Unknown or Not Reported | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 6 | 0 | 9 |
| Race (NIH/OMB)(Participants) | Dose Escalation - Schedule A: IMGN632 0.015 mg/kg | Dose Escalation - Schedule A: IMGN632 0.045 mg/kg | Dose Escalation - Schedule A: IMGN632 0.09 mg/kg | Dose Escalation - Schedule A: IMGN632 0.18 mg/kg | Dose Escalation - Schedule A: IMGN632 0.3 mg/kg | Dose Escalation - Schedule A: IMGN632 0.45 mg/kg | Dose Escalation - Schedule B: IMGN632 0.015 mg/kg | Dose Escalation - Schedule B: IMGN632 0.03 mg/kg | Dose Escalation - Schedule B: IMGN632 0.06 mg/kg | Dose Expansion - Schedule A: IMGN632 0.045 mg/kg | Dose Expansion - Schedule A: IMGN632 0.09 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 4 | 1 | 10 |
| White | 2 | 12 | 10 | 7 | 5 | 2 | 3 | 5 | 13 | 86 | 9 | 154 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 13 | 0 | 13 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Pivekimab sunirine
Blastic Plasmacytoid Dendritic Cell Neoplasm →