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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
City of Hope National Medical Center
Duarte, California, United States
University of Chicago Medicine
Chicago, Illinois, United States
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
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Washington University School of Medicine- Siteman Cancer Center
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
University Of Texas, MD Anderson Cancer Center
Houston, Texas, United States
University Of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
McGill University Health Centre Glen Site
Montreal, Quebec, Canada
...and 7 more locations
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