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:

Il s’agit d’une étude sur l’emploi de l’ADP-A2M4 génétiquement modifié chez des sujets atteints d’un liposarcome myxoïde/à cellules rondes (LSMCR) ou d’un sarcome synovial métastatique ou inopérable (de stade avancé) exprimant le HLA-A*02, qui ont reçu une chimiothérapie et dont la tumeur exprime l’antigène tumoral MAGE-A4.

Description de l'essai

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
• 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