Surpass: ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Tumours

Titre officiel

A Phase 1 Dose Escalation Study To Assess Safety And Efficacy Of ADP-A2M4CD8 In HLA-A2+ Subjects With MAGE-A4 Positive Tumours

Sommaire:

This study will investigate the safety and tolerability of ADP-A2M4CD8 T-cell therapy in subjects who have the appropriate human leukocyte antigen (HLA) and tumour antigen status and whose synovial sarcoma, myxoid/round cell liposarcoma (MRCLS), melanoma, urothelial, head and neck, ovarian, gastric (stomach), esophagogastric junction (EGJ), non-small cell lung (NSCLC), or esophageal cancer that express the MAGE-A4 protein.

Description de l'essai

Primary Outcome:

  • 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
  • Evaluate safety of ADP-A2M4CD8 through measurement of Replication -competent Retrovirus in genetically engineered T-cells
Secondary Outcome:
  • Anti-tumour activity: Overall Response Rate (ORR)
  • Anti-tumour activity: Best overall response (BOR)
  • Time to response (TTR)
  • Duration of Response (DOR)
  • Duration of stable disease (DoSD)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)

Voir cet essai sur ClinicalTrials.gov

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