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Protocol # 19-477

Status

Recruiting

Description

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) .

Condition

  • Synovial Sarcoma
  • Myxoid Liposarcoma

Interventions

  • afamitresgene autoleucel (previously ADP-A2M4)

Phase

Phase 2

Study Type

Interventional

Further Study Details

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

Enrollment

90

Study Start Date

August 13, 2019

Eligibility

  • Gender:     All
  • Minimum age:     10 Years
  • Maximum age:     75 Years
  • Healthy volunteers:     No

Sponsors

Adaptimmune

Source

Adaptimmune

Official title

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

Clinicaltrials.gov Identifier

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.