A Phase 2 interventional study of Autologous genetically modified ADP-A2M4CD8 cells in Esophageal Cancer and Esophagogastric Junction Cancer, sponsored by Adaptimmune. Terminated at 17 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Adaptimmune · Phase 2, Interventional, and Treatment
This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumor antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 3 is below the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Adaptimmune is the lead sponsor of 13 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Note: other protocol defined Inclusion criteria may apply
Key exclusion criteria
Note: other protocol defined Inclusion/Exclusion criteria may apply.
Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
Overall Response Rate (ORR) by Independent Radiological Assessment Committee (IRAC)
Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC
Time frame: From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
Number and Percentage of Participants With Adverse Events (AEs) Including Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESI)
An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAEs), SAEs and AESI including cytokine release syndrome, ICANS, and prolonged cytopenia are presented.
Time frame: From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months)
Time to Response (TTR) by IRAC
TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR.
Time frame: From T-cell infusion until first documented confirmed CR or PR
Duration of Response (DoR) by IRAC
DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by IRAC.
Time frame: From initial date of first confirmed response (CR or PR) until PD or death
Best Overall Response (BOR) by IRAC
BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by IRAC. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).
Time frame: From T-cell infusion until disease progression
Progression Free Survival (PFS) by IRAC
PFS is defined as time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by IRAC or death due to any cause, whichever occurs first.
Time frame: From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first
Overall Response Rate (ORR) by Investigator Assessment
Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Assessment
Time frame: From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion).
Time to Response (TTR) by Investigator Assessment
TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR
Time frame: From T-cell infusion until first documented confirmed CR or PR
Duration of Response (DoR) by Investigator Assessment
DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by Investigator Assessment.
Time frame: From initial date of first confirmed response (CR or PR) until PD or death
Best Overall Response (BOR) by Investigator Assessment
BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by the Investigator. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).
Time frame: From T-cell infusion until disease progression (Up to 5 months)
Progression Free Survival (PFS) by Investigator Assessment
PFS is defined as the time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by investigator assessment or death due to any cause, whichever occurs first.
Time frame: From T-cell infusion until first documented PD, as assessed by Investigator, or death due to any cause, whichever occurs first (up to 5 months)
Overall Survival (OS)
OS is defined as the time from the date of first T-cell infusion to the date of death (due to any cause).
Time frame: From T-cell infusion to death due to any reason (up to 7 months)
Replication Competent Lentivirus
The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. 1 participant had at least 1 post-infusion sample tested for RCL. The count of participants with RCL post-infusion is presented.
Time frame: From T-cell infusion to end study (up to 7 months)
Insertional Oncogenesis (IO)
Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples are subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The outcome measure is the number of participants with integration sites representing more than 5% of all unique sites.
Time frame: From 1 year post T-cell infusion
Peak Persistence
Peak persistence of ADP-A2M4CD8 cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
Time frame: From T-cell infusion to end study (up to 7 months)
Time to Peak Persistence
Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells.
Time frame: From T-cell infusion to end study (up to 7 months)
Concordance of the MAGE A-4 Clinical Trial Assay and in Vitro Diagnostic (IVD) Kit.
Concordance of the MAGE A-4 clinical trial assay and in vitro diagnostic (IVD) kit.
Time frame: Screening visit
This was a Phase 2 open-label, single treatment, clinical trial of ADP-A2M4CD8 in participants with advanced esophageal or esophagogastric junction cancers
| Milestone | Esophageal | Esophagogastric Junction |
|---|---|---|
| Started | 2 | 1 |
| Completed | 0 | 0 |
| Not completed | 2 | 1 |
| Withdrew: Death | 2 | 1 |
Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC
No measurements were reported for this outcome.
An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAEs), SAEs and AESI including cytokine release syndrome, ICANS, and prolonged cytopenia are presented.
| Participants | Esophageal | Esophagogastric Junction |
|---|---|---|
| AE | 2 | 1 |
| SAE | 1 | 1 |
| AESI - cytokine release syndrome | 1 | 1 |
| AESI- ICANS | 0 | 0 |
| AESI- Prolonged cytopenia | 0 | 1 |
TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR.
No measurements were reported for this outcome.
DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by IRAC.
No measurements were reported for this outcome.
BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by IRAC. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).
No measurements were reported for this outcome.
PFS is defined as time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by IRAC or death due to any cause, whichever occurs first.
No measurements were reported for this outcome.
Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Assessment
| Participants | Esophageal | Esophagogastric Junction |
|---|---|---|
| Overall Response Rate (ORR) by Investigator Assessment | 0 | 0 |
TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR
No measurements were reported for this outcome.
DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by Investigator Assessment.
No measurements were reported for this outcome.
BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by the Investigator. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).
| Participants | Esophageal | Esophagogastric Junction |
|---|---|---|
| Complete Response | 0 | 0 |
| Partial Response | 0 | 0 |
| Stable Disease | 2 | 1 |
| Progressive Disease | 0 | 0 |
PFS is defined as the time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by investigator assessment or death due to any cause, whichever occurs first.
| Weeks | Esophageal | Esophagogastric Junction |
|---|---|---|
| Progression Free Survival (PFS) by Investigator Assessment | 14.43 (8.14 to 20.71) | 8.43 (8.43 to 8.43) |
OS is defined as the time from the date of first T-cell infusion to the date of death (due to any cause).
| Weeks | Esophageal | Esophagogastric Junction |
|---|---|---|
| Overall Survival (OS) | 19.64 (18.57 to 20.71) | 29.71 (29.71 to 29.71) |
The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. 1 participant had at least 1 post-infusion sample tested for RCL. The count of participants with RCL post-infusion is presented.
| Participants | Esophageal | Esophagogastric Junction |
|---|---|---|
| Replication Competent Lentivirus | 0 | 0 |
Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples are subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The outcome measure is the number of participants with integration sites representing more than 5% of all unique sites.
No measurements were reported for this outcome.
Peak persistence of ADP-A2M4CD8 cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).
| copies/microgram DNA | Esophageal | Esophagogastric Junction |
|---|---|---|
| Peak Persistence | 59546.3 (41432.7 to 77660) | 135581.5 (135581.5 to 135581.5) |
Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells.
| Days | Esophageal | Esophagogastric Junction |
|---|---|---|
| Time to Peak Persistence | 11.5 (8 to 15) | 17 (17 to 17) |
Concordance of the MAGE A-4 clinical trial assay and in vitro diagnostic (IVD) kit.
No measurements were reported for this outcome.
Collected over Serious adverse events were collected from the start of lymphodepleting chemotherapy until the end of the interventional phase (up to 5 months). Deaths were collected from start of lymphodepletion chemotherapy until the end of the study (up to 7 months).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Esophageal | 2/2 (100%) | 1/2 (50%) | 2/2 (100%) |
| Esophagogastric Junction | 1/1 (100%) | 1/1 (100%) | 1/1 (100%) |
| Event | Esophageal | Esophagogastric Junction |
|---|---|---|
| Cytokine release syndromeImmune system disorders | 0/2 | 1/1 |
| Oesophageal haemorrhageGastrointestinal disorders | 0/2 | 1/1 |
| PyrexiaGeneral disorders | 0/2 | 1/1 |
| Respiratory FailureRespiratory, thoracic and mediastinal disorders | 1/2 | 0/1 |
| Event | Esophageal | Esophagogastric Junction |
|---|---|---|
| VomitingGastrointestinal disorders | 2/2 | 1/1 |
| NauseaGastrointestinal disorders | 2/2 | 0/1 |
| Abdominal painGastrointestinal disorders | 0/2 | 1/1 |
| DiarrhoeaGastrointestinal disorders | 0/2 | 1/1 |
| PyrexiaGeneral disorders | 1/2 | 1/1 |
| Lymphocyte count decreasedInvestigations | 1/2 | 1/1 |
| Neutrophil count decreasedInvestigations | 1/2 | 1/1 |
| White blood cell count decreasedInvestigations | 1/2 | 1/1 |
| Platelet count decreasedInvestigations | 0/2 | 1/1 |
| Migraine with auraNervous system disorders | 0/2 | 1/1 |
Eligible participants who received ADP-A2M4CD8 as a single infusion
| Age, Categorical(Participants) | Esophageal | Esophagogastric Junction | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 2 | 1 | 3 |
| Age, Continuous(years) | Esophageal | Esophagogastric Junction | Total |
|---|---|---|---|
| Median | 68 (67 to 69) | 72 (72 to 72) | 69 (67 to 72) |
| Sex: Female, Male(Participants) | Esophageal | Esophagogastric Junction | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Esophageal | Esophagogastric Junction | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 2 | 1 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Esophageal | Esophagogastric Junction | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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