| Primary | 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 | Participants who received ADP-A2M4CD8. No subject images were assessed by Independent Reviewer due to lack of efficacy observed on Investigator review. Thus, no results are reported. | Posted | | | | | No | From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion). | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 | Posted | | Count of Participants | | Participants | | From start of lymphodepleting chemotherapy to end of Interventional Phase (up to 5 months) | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, no results are reported. | Posted | | | | | | From T-cell infusion until first documented confirmed CR or PR | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, no results are reported. | Posted | | | | | | From initial date of first confirmed response (CR or PR) until PD or death | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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). | Participants who received ADP-A2M4CD8. No subject images were assessed by Independent Reviewer due to lack of efficacy observed on Investigator review. Thus, no results are reported. | Posted | | | | | | From T-cell infusion until disease progression | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8. No subject images were assessed by IRAC due to lack of efficacy observed on Investigator review. Hence, no results are reported. | Posted | | | | | | From T-cell infusion until first documented PD, as assessed by IRAC, or death due to any cause, whichever occurs first | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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 | Participants who received ADP-A2M4CD8. | Posted | | Count of Participants | | Participants | | From T-cell infusion to end of Interventional Phase (Up to 5 months from T-cell infusion). | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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 | Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, TTR was not calculated, and no results are reported. | Posted | | | | | | From T-cell infusion until first documented confirmed CR or PR | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 and had a confirmed CR or PR. No subjects had a confirmed CR or PR. Thus, DoR was not calculated, and no results are reported. | Posted | | | | | | From initial date of first confirmed response (CR or PR) until PD or death | | | | ID | Title | Description |
|---|
| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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). | Participants who received ADP-A2M4CD8. | Posted | | Count of Participants | | Participants | | From T-cell infusion until disease progression (Up to 5 months) | | | | ID | Title | Description |
|---|
| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 | Posted | | Median | Full Range | Weeks | | 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) | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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). | Participants who received ADP-A2M4CD8 | Posted | | Median | Full Range | Weeks | | From T-cell infusion to death due to any reason (up to 7 months) | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 and had a post-infusion sample tested for VSV-G | Posted | | Count of Participants | | Participants | | From T-cell infusion to end study (up to 7 months) | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion and a post-infusion sample tested for VSV-G (RCL) | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion and a post-infusion sample tested for VSV-G (RCL) |
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| Secondary | 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. | Participants who received ADP-A2M4CD8 and had a sample analyzed for IO. All subjects died prior to 1 year post T-cell infusion, subsequently no samples were obtained or analyzed. | Posted | | | | | | From 1 year post T-cell infusion | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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). | Participants who received ADP-A2M4CD8 | Posted | | Median | Full Range | copies/microgram DNA | | From T-cell infusion to end study (up to 7 months) | | | | ID | Title | Description |
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| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | Time to Peak Persistence | Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells. | Participants who received ADP-A2M4CD8 | Posted | | Median | Full Range | Days | | From T-cell infusion to end study (up to 7 months) | | | | ID | Title | Description |
|---|
| OG000 | Esophageal | Eligible participants with esophageal cancer who received ADP-A2M4CD8 as a single infusion | | OG001 | Esophagogastric Junction | Eligible participants with esophagogastric junction cancer who received ADP-A2M4CD8 as a single infusion |
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| Secondary | 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. | Due to study termination, an IVD kit for companion diagnosis was not developed. Thus, there is no data to report regarding concordance of the MAGE A-4 clinical trial assay and the IVD companion diagnostic kit. | Posted | | | | | | Screening visit | | | | ID | Title | Description |
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| OG000 | All Screened Participants | All participants who were screened and had slides available for MAGE A4 assay |
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