ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)
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|ClinicalTrials.gov Identifier: NCT04752358|
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : November 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Esophagogastric Junction Cancer||Genetic: Autologous genetically modified ADP-A2M4CD8 cells||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers|
|Actual Study Start Date :||September 15, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||October 2038|
|Experimental: Autologous genetically modified ADP-A2M4CD8 cells||
Genetic: Autologous genetically modified ADP-A2M4CD8 cells
Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
- Efficacy: 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
- 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)
- Efficacy: Best overall response (BOR) [ Time Frame: 2.5 Years ]Best Overall Response (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.
- 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.
- Invitro diagnostic (IVD) assay for screening [ Time Frame: 2.5 years ]Development and validation of the MAGE-A4 antigen expression companion diagnostic assay
- Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs [ Time Frame: 2.5 years ]Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs by flow cytometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752358