Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Titre officiel

A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T Cells in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma

Sommaire:

This is a study of genetically engineered ADP-A2M4 in HLA-A*02 subjects with metastatic or inoperable (advanced) Synovial Sarcoma or MRCLS who have received prior chemotherapy and whose tumour expresses the MAGE-A4 tumour antigen.

Description de l'essai

Primary Outcome:

  • Efficacy: Overall Response Rate (ORR)
Secondary 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-A2M4 through measurement of Replication -competent Retrovirus in genetically engineered T-cells
  • Measurement of T-cell clonality and insertional oncogenesis in peripheral blood mononuclear cells (PBMCs).
  • Efficacy: Best overall response (BOR)
  • Time to response (TTR)
  • Duration of Response (DoR)
  • Progression Free Survival (PFS)
  • Overall Survival (OS)
  • Quantitation of genetically engineered T-cells in PBMCs
  • Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs
  • Quantitation of genetically engineered T-cells in PBMCs
  • Time taken to achieve peak expansion of genetically engineered T-cells in PBMCs
  • Invitro diagnostic (IVD) assay for screening

Voir cet essai sur ClinicalTrials.gov

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