Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumors
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|ClinicalTrials.gov Identifier: NCT04044859|
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Head and Neck Gastric Cancer Esophagogastric Junction Disorder Nonsmall Cell Lung Cancer Esophageal Cancer||Genetic: Autologous genetically modified ADP-A2M4CD8 cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumors|
|Actual Study Start Date :||August 20, 2019|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2037|
|Experimental: Autologous genetically modified ADP-A2M4CD8 cells||
Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
- Number of subjects with treatment -related adverse events (AEs), including serious adverse events (SAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 [ Time Frame: 2.5 years ]Determine if treatment with ADP-A2M4CD8 is safe and tolerable through assessment of adverse events (AEs) including Serious Adverse Events (SAEs)
- Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells [ Time Frame: 15 years ]Evaluation of RCL using PCR -based assay in peripheral blood.
- Anti-tumour activity: Overall Response Rate (ORR) [ Time Frame: 2.5 years ]ORR is defined as incidence of complete responses or partial responses as assessed by RECIST v1.1
- Anti-tumor activity: Best overall response (BOR) [ Time Frame: 2.5 years ]BOR is per RECIST V1.1.
- Time to response (TTR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4CD8, the time taken from date of infusion to achieve a partial response or complete response (TTR) is assessed
- Duration of Response (DOR) [ Time Frame: 2.5 years ]For patients who are observed to respond to ADP-A2M4CD8, the DOR is the date of initial response (including confirmation) from date of infusion up until disease progression per RECIST v 1.1 or death.
- Duration of stable disease (DoSD) [ Time Frame: 2.5 years ]For patients who are observed to have stable disease by RECIST v 1.1, the duration of period of stable disease until disease progression or death
- Progression Free Survival (PFS) [ Time Frame: 2.5 years ]PFS is assessed from date of infusion of ADP-A2M4CD8 up until the date of disease progression per RECIST v1.1 or death.
- Overall Survival (OS) [ Time Frame: 15 years ]OS is assessed from date of infusion of ADP-A2M4CD8 up until the date of patient death.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044859
|Contact: David Hong, MDfirstname.lastname@example.org|
|Principal Investigator:||David Hong, MD||M.D. Anderson Cancer Center|