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ACTIVE NOT RECRUITING
NCT03132922
PHASE1

MAGE-A4ᶜ¹º³²T for Multi-Tumor

Sponsor: Adaptimmune

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

71

Start Date

2017-05-15

Completion Date

2032-09

Last Updated

2024-01-22

Healthy Volunteers

No

Interventions

GENETIC

Autologous genetically modified MAGE-A4ᶜ¹º³²T cells

Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1

RADIATION

Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation

Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells

Locations (11)

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