A Phase 1/2 interventional study of MK-1045 in Acute Lymphoblastic Leukemia, sponsored by MSD R&D (China) Co., Ltd.. Recruiting at 11 sites in China. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.
Sponsored by MSD R&D (China) Co., Ltd. · Phase 1/2, Interventional, and Treatment
Researchers are looking for new ways to treat people with a type of blood cancer called precursor B-cell Acute Lymphoblastic Leukemia (B-ALL) that is relapsed- the cancer has come back after treatment, or refractory - the current treatment has stopped working to slow or stop cancer growth. This study will have two parts. In the first part (dose escalation phase) the goal is to learn about the safety of a study treatment, MK-1045, and to find the best dose level of MK-1045 that is tolerated and may work to treat B-ALL. In the second part (Phase II) researchers want to learn how well MK-1045 works to treat B-ALL.
2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.
This study's planned enrollment of 203 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.
Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →MSD R&D (China) Co., Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The main inclusion criteria include but are not limited to:
Participants with Ph-negative B-ALL with any of the following refractory/relapse criteria:
The main exclusion criteria include but are not limited to:
Adults in the dose escalation phase will receive a target dose level of MK-1045 from 600 μg to 120,000 μg, administered by intravenous (IV) infusion. MK-1045 will be administered once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.
Drug: MK-1045
Pediatric participants will receive a target dose level of MK-1045 from 320 μg to 60000 μg, with dosing further based upon weight. MK-1045 will be administered by IV infusion once per week, in treatment cycles defined as 4 weeks of MK-1045 treatment.
Drug: MK-1045
MK-1045 is administered by IV infusion once a week (QW), 4 weeks per treatment cycle, starting with 2 cycles of induction treatment. After a 2-week treatment-free interval, responders to induction treatment receive 3 cycles of consolidation therapy, and up to 7 cycles of maintenance treatment or until intolerable toxicity, disease progression, withdrawal of informed consent, loss to follow-up, receipt of other antitumor therapy, or death, whichever occurs first.
Also known as: CN201
Dose Escalation Phase: Number of Participants who Experience at Least One Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 24 months
Dose Escalation Phase: Number of Participants who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 21 months
Dose Escalation Phase: Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
A DLT is defined as any of the following toxicities and judged by the investigator to be related to the study drug: Hematologic toxic reactions: If thrombocytopenia, leukopenia, and anemia are caused by primary leukemia, they are not considered as DLTs. Non-Hematologic toxic reactions: Grade 4 non-hematologic toxicity that does not recover to ≤ Grade 2 within 14 days of best supportive therapy. Grade 3 rash, fatigue, fever, or infection will not be classified as DLT; other Grade 3 non-hematologic toxicities that do not recover to ≤ Grade 2 within 14 days of best supportive therapy is considered DLTs. Others that are considered as DLTs: Other toxicities considered clinically significant by the investigator that result in permanent drug withdrawal.
Time frame: Up to 28 days
Dose Escalation Phase: Maximum Tolerated Dose (MTD) of MK-1045
The MTD will be determined based on the incidence of DLT in each dose level. The dose level for which the DLT rate is closest to the target DLT rate (30%) will be selected as the MTD.
Time frame: Up to approximately 21 months
Phase II: Complete Remission (CR) Rate
Complete remission is defined as follows: \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L. The number of participants with CR will be presented.
Time frame: Up to approximately 10 weeks
Dose Escalation Phase: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-1045
Blood samples will be collected to determine the AUC from time 0 to the last concentration that can be accurately measured of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of MK-1045
Blood samples will be collected to determine the AUC0-inf of MK-1045.
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Area Under the Concentration-time Curve From Time 0 to 168 hours (AUC0-168)
Blood samples will be collected to determine the AUC from time to 168 hours after the start of infusion of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: AUC From Time 0 to 168 Hours at Steady State (AUC0-tau)
Blood samples will be collected to determine the AUC0 -tau
Time frame: At designated time points up to 24 weeks
Dose Escalation Phase: Maximum Serum Drug Concentration (Cmax) of MK-1045
Blood samples will be collected to determine the maximum serum drug concentration, obtained directly from the measured value of the plasma concentration-time curve
Time frame: At designated time points up to approximately 32 weeks
Dose Escalation Phase: Time to Maximum Serum Drug Concentration of MK-1045
Blood samples will be collected to determine the Tmax of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Blood samples will be collected to determine the Ctrough of MK-1045
Time frame: At designated time points up to approximately 12 months
Dose Escalation Phase: Apparent Terminal Half Life (t1/2)
Blood samples will be collected to determine the t1/2 of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Clearance (CL) of MK-1045
Blood samples will be collected to determine the CL of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution (Vz) of MK-1045
Blood samples will be collected to determine the Vz of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Apparent Volume of Distribution at Theoretical Steady State (Vss) of MK-1045
Blood samples will be collected to determine the Vss of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Mean Residence Time (MRT) of MK-1045
Blood samples will be collected to determine the MRT of MK-1045
Time frame: At designated time points up to approximately 24 weeks
Dose Escalation Phase: Peripheral B Cell Depletion of MK-1045
B cell depletion will be determined at each timepoint by comparing absolute B cell numbers (as determined by flow cytometry) with those at baseline
Time frame: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Peripheral Circulating T Cell Activation of of MK-1045
Peripheral circulating T cell activation will be determined at each timepoint by comparing absolute T cell numbers and T cell activation markers with those at baseline
Time frame: Baseline and at designated time points up to approximately 12 months
Dose Escalation Phase: Percentage of Participants with Antidrug Antibodies (ADA) to MK-1045
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045
Time frame: At designated time points up to approximately 12 months
Dose Escalation Phase: Rate of Complete Remission (CR) and Complete Remission with Partial Hematologic Recovery (CRh)
Complete remission is defined as follows: \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L. CRh is defined as meeting all of the following criteria: Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L). The percentage of participants with CR or CRh will be presented.
Time frame: Up to approximately 10 weeks
Dose Escalation Phase: Rate of CR, CRh, and Complete Response with Incomplete Hematologic Recovery (CRi)
Complete remission is defined as follows: \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L. CRh is defined as meeting all of the following criteria: Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L). CRi is defined as follows: \<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets \<100×10\^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils \<1.0×10\^9/L. The percentage of participants with CR, CRh or CRi will be presented.
Time frame: Up to approximately 10 weeks
Dose Escalation Phase: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
MRD-negative is defined as less than 0.01% of leukemic cells were detected in bone marrow with a detection sensitivity no less than 10\^-4.
Time frame: Up to approximately 12 months
Dose Escalation Phase: Rate of Red Blood Cell and Platelet Transfusion Independence (TI)
TI is defined as no transfusion for a period of at least 1 week (7 days). The percentage of participants having TI will be presented.
Time frame: Up to approximately 24 months
Phase II: Number of Participants Who Experience at Least 1 AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 24 months
Phase II: Number of Participants who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Time frame: Up to approximately 24 months
Phase II: Maximum Serum Drug Concentration (Cmax) of MK-1045
Blood samples will be collected to determine the maximum serum drug concentration, obtained directly from the measured value of the plasma concentration-time curve
Time frame: At designated time points up to 4 weeks
Phase II: Concentration at End of Dosing Interval (Ctrough) of MK-1045
Blood samples will be collected to determine the Ctrough of MK-1045
Time frame: At designated time points up to 4 weeks
Phase II: Peripheral B Cell Depletion of MK-1045
B cell depletion will be determined at each timepoint by comparing absolute B cell numbers (as determined by flow cytometry) with those at baseline
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Peripheral Circulating T Cell Activation of of MK-1045
Peripheral circulating T cell activation will be determined at each timepoint by comparing absolute T cell numbers and T cell activation markers with those at baseline
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Concentration of Peripheral Cytokines
Blood samples will be collected to compare peripheral blood cytokine levels at various time points with those at baseline
Time frame: Baseline and at designated time points up to 4 weeks
Phase II: Percentage of participants with Antidrug Antibodies (ADA) to MK-1045
Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045
Time frame: At designated time points up to 4 weeks
Phase II: Rate of CR and CRh
Complete remission is defined as follows: \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L. CRh is defined as meeting all of the following criteria: Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L). The percentage of participants with CR or CRh will be presented.
Time frame: Up to approximately 10 weeks
Phase II: Rate of CR/CRh/CRi
CR is defined as follows: \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L. CRh is defined as meeting all of the following criteria: Satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L). CRi is defined as follows: \<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets \<100×10\^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils \<1.0×10\^9/L. The percentage of participants with CR, CRh or CRi will be presented.
Time frame: Up to approximately 10 weeks
Phase II: Rate of Minimum Residual Disease (MRD)-negative Complete Remission
MRD-negative is defined as less than 0.01% of leukemic cells were detected in bone marrow with a detection sensitivity no less than 10\^-4.
Time frame: Up to approximately 24 months
Phase II: Rate of Red Blood Cell and Platelet TI
Red Blood Cell and Platelet TI is defined as no transfusion for a period of at least 1 week (7 days). The percentage of participants having TI will be presented.
Time frame: Up to approximately 24 months
Phase II: Proportion of Participants Undergoing Hematopoietic Stem Cell Transplantation (HSCT)
The number of participants who undergo a HSCT during study participation will be presented.
Time frame: Up to approximately 24 months
Phase II: Duration of CR
For participants who demonstrate a CR (defined as \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L) , duration of CR is defined as the time from the first documentation of a disease response of CR to the date of the first documented relapse event, or death due to any cause, whichever occurs first
Time frame: Up to approximately 24 months
Phase II: Duration of CR/CRh
Duration of CR/CRh is defined as the time from the first documentation of a disease response of CR/CRh to the date of the first documented relapse event, or death due to any cause, whichever occurs first. Only participants who demonstrate a CR (defined as \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L), or CRh \[satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L)\] will be analyzed.
Time frame: Up to approximately 24 months
Phase II: Duration of CR/CRh/CRi
Duration of CR/CRh/CRi is defined as the time from the first documentation of a disease response of CR/CRh/CRi to the date of the first documented relapse event, or death due to any cause, whichever occurs first. Only participants who demonstrate a CR (defined as \< 5% blasts in the bone marrow, no circulating lymphoblasts or extramedullary disease, and full recovery of peripheral blood counts: Platelets ≥100×10\^9/L, and absolute neutrophil count (ANC) ≥1.0×10\^9/L), or CRh \[satisfaction of all criteria for CR except partial recovery of peripheral blood counts (platelets ≥ 50 ×10\^9/L and ANC ≥ 0.5×10\^9/L)\], or CRi (\<5% blasts in the bone marrow, No circulating lymphoblasts or extramedullary disease, and platelets \<100×10\^9/L and neutrophils ≥1.0×109/L or platelets ≥100 ×109/L and neutrophils \<1.0×10\^9/L) will be analyzed.
Time frame: Up to approximately 24 months
Phase II: Relapse-Free Survival (RFS)
RFS is defined as the time from the first dose of MK-1045 to the first documented relapse, or death due to any cause (whichever occurs first). In participants who achieve CR, CRh or CRi, relapse is defined as either hematological or extramedullary relapse . Hematological relapse is defined as recurrence of blasts in the blood, or \>5% blasts in bone marrow. Extramedullary relapse is defined as recurrence of extramedullary disease after a CR.
Time frame: Up to approximately 24 months
Phase II: Overall Survival (OS)
OS is the time from date of first study treatment to the date of death due to any reason.
Time frame: Up to approximately 24 months
Plan to share: Yes — https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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MSD R&D (China) Co., Ltd.