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Brief Title: MAGE-A4ᶜ¹º³²T for Multi-Tumor
Official Title: Phase 1 Dose Escalation, Multi-tumor Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered MAGE-A4ᶜ¹º³²T in HLA-A2+ Subjects With MAGE-A4 Positive Tumors
Study ID: NCT03132922
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Miami, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Washington University, Saint 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
Name: David Hong, MD
Affiliation: M.D. Anderson Cancer Center
Role: PRINCIPAL_INVESTIGATOR