MAGE-A4ᶜ¹º³²T for Multi-Tumor
NCT03132922 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71
Last updated 2026-05-07
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.
Conditions
- 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
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
Sponsors & Collaborators
-
USWM CT, LLC
lead INDUSTRY
Principal Investigators
-
David Hong, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-15
- Primary Completion
- 2022-12-27
- Completion
- 2032-09-30
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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