MAGE-A4ᶜ¹º³²T for Multi-Tumor

Running, not enrolling · Phase 1

Conditions studied: Urinary Bladder Cancer, Melanoma, Head and Neck Cancer, Ovarian Cancer, Non-Small Cell Lung Cancer, Esophageal Cancer, Gastric Cancer, Synovial Sarcoma, Myxoid Round Cell Liposarcoma, Gastroesophageal Junction

In brief

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.

Key facts

Study ID: NCT03132922
Run by: USWM CT, LLC
People needed: 71
Starts: 2017-05-15
Expected to finish: 2032-09-01
Last updated by the study team: 2026-06-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is ≥18 to 75 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.

You may not qualify if…

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.

Where it is running

University of Miami — Miami, Florida, United States
Moffitt Cancer Center — Tampa, Florida, United States
Washington University School of Medicine — St Louis, Missouri, United States
Washington University — St Louis, Missouri, United States
Roswell Park Cancer Institute — Buffalo, New York, United States
Duke University Medical Center, Duke Cancer Institute — Durham, North Carolina, United States
Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Tennessee Oncology - Sarah Cannon Research Institute — Nashville, Tennessee, United States
M.D. Anderson Cancer Center — Houston, Texas, United States
Princess Margaret Cancer Centre — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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