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 : November 18, 2021
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Head and Neck Gastric Cancer Esophagogastric Junction Disorder Nonsmall Cell Lung Cancer Esophageal Cancer Ovarian Cancer||Genetic: Autologous genetically modified ADP-A2M4CD8 cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 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 :||September 30, 2023|
|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.
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): NCT04044859
|Contact: David Hong, MDfirstname.lastname@example.org|
|Principal Investigator:||David Hong, MD||M.D. Anderson Cancer Center|