Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
NCT06964737 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-08
Summary
This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and/or effective in treating patients with recurrent grade III or IV gliomas.
Conditions
- Recurrent Malignant Glioma
- Recurrent WHO Grade 3 Glioma
- Recurrent WHO Grade 4 Glioma
- WHO Grade 2 Glioma
- WHO Grade 3 Glioma
- WHO Grade 4 Glioma
Interventions
- BIOLOGICAL
-
Anti-GARP Chimeric Antigen Receptor-T Cells
Given intracavitary
- PROCEDURE
-
Biospecimen Collection
Undergo collection of CSF and blood samples
- PROCEDURE
-
Chest Radiography
Undergo chest x-ray
- PROCEDURE
-
Echocardiography Test
Undergo ECHO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Multigated Acquisition Scan
Undergo MUGA
- PROCEDURE
-
Pheresis
Undergo apheresis
- PROCEDURE
-
Surgical Procedure
Undergo surgery and placement of CSF reservoir
Sponsors & Collaborators
-
Ohio State University Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
James B Elder, MD · Ohio State University Comprehensive Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-21
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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