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This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1 and Cohort 2) or MRCLS (Cohort 1) .
- Synovial Sarcoma
- Myxoid Liposarcoma
- afamitresgene autoleucel (previously ADP-A2M4)
Phase 2
Interventional
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
90
August 13, 2019
- Gender: All
- Minimum age: 10 Years
- Maximum age: 75 Years
- Healthy volunteers: No
Adaptimmune
Adaptimmune
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
NCT04044768
Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.