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MAGE-A4ᶜ¹º³²T for Multi-Tumor

Trial Status: Active

This study will investigate the safety and tolerability of MAGE-A4ᶜ¹º³²T cell therapy in subjects who have the appropriate HLA-A2 tissue marker and whose urinary bladder, melanoma, head and neck, ovarian, non-small cell lung, esophageal, gastric, synovial sarcoma, or myxoid / round call liposarcoma (MRCLS) tumor has the MAGE-A4 protein expressed. This study will take a subject's T cells and give them a T cell receptor protein that recognizes and attacks the tumors. This study has a substudy component that will investigate the safety and tolerability of MAGE-A4c1032T cell therapy in combination with low dose radiation in up to 10 subjects.

Inclusion Criteria

  • Subject is ≥18 years of age at the time of signing the study informed consent.
  • Subject has histologically confirmed diagnosis of any one of the indicated tumor types
  • Subject is HLA-A*02 positive. (This determination will be made under screening protocol ADP-0000-001).
  • Subject's tumor shows expression of the MAGE-A4 RNA or protein. (This determination will be made under screening protocol ADP-0000-001).
  • Adequate organ function as indicated in the study protocol
  • Subject has measurable disease according to RECIST v1.1 criteria prior to lymphodepletion
  • Subject meets disease-specific requirements per protocol
  • Subject has anticipated life expectancy > 6 months prior to leukapheresis and >3 months prior to lymphodepletion.

Exclusion Criteria

  • Subject does not express appropriate HLA-A genotype
  • Subject is receiving excluded therapy/treatment per protocol
  • Subject has symptomatic CNS metastases.
  • Subject has any other active malignancy besides the tumor under study within 3 years prior to Screening. Subject has uncontrolled intercurrent illness.
  • Subject has active infection with HIV, HBV, HCV or HTLV
  • Subject is pregnant or breastfeeding. Additional Exclusion Criteria for the Radiation Substudy:
  • Subject does not meet eligibility criteria for the main study (ADP-0044-001).
  • Subject does not have at least one target lesion amenable to radiation.
  • Certain radiation therapy within 6 months of clinical trial are an exclusion.
  • Metastatic disease impinging on the spinal cord or threatening spinal cord compression.

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: COMPLETED
Tampa
Moffitt Cancer Center
Status: COMPLETED

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New York

Buffalo
Roswell Park Cancer Institute
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: APPROVED

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Pennsylvania

Philadelphia
Fox Chase Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE
Contact: Danxia Ke
Phone: 713-792-4384

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Adaptimmune Limited

  • Primary ID ADP-0044-001
  • Secondary IDs NCI-2017-01505
  • Clinicaltrials.gov ID NCT03132922