ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Official Title

A Phase 2 Open-Label Clinical Trial of ADP-A2M4CD8 in Subjects With Advanced Esophageal or Esophagogastric Junction Cancers

Summary:

This study will investigate the efficacy of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumour antigen status and whose esophageal or esophagogastric junction (EGJ) cancer expresses the MAGE-A4 protein.

Trial Description

Primary Outcome:

• Efficacy: Overall Response Rate (ORR)

• 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
• Efficacy: Best overall response (BOR)
• Time to response (TTR)
• Duration of Response (DoR)
• Progression Free Survival (PFS)
• Overall Survival (OS)
• Invitro diagnostic (IVD) assay for screening
• Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs

View this trial on ClinicalTrials.gov