Actively Recruiting
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients are 18 years old or older
- Able to understand and willing to provide written informed consent
- Diagnosis or clinical suspicion of recurrent malignant glioma, including history of grade III or IV glioma or prior grade II glioma with new high-grade features
- Imaging or biopsy confirmation of recurrent disease with measurable tumor
- Unifocal tumor in one brain hemisphere, located away from critical brain areas (brainstem, motor cortex, visual cortex)
- If on steroids, must be on low dose (4 mg or less per day) and not increasing dose at enrollment
- Must not have received bevacizumab or planned to start it
- Karnofsky Performance Score of 60 or higher
- Candidate for surgery aiming to remove more than 80-90% of tumor
- White blood cell count above 4,000 cells/uL
- Hemoglobin above 7 gm/dL
- Platelet count above 100/dL
- Kidney and liver function tests within 1.5 times the normal upper limit
- Women of reproductive potential must have negative pregnancy test within 7 days before study start
- Use physician-approved contraception and avoid sperm donation from two weeks before until six months after final infusion
- Women must avoid breastfeeding for six months after treatment
- Sufficient venous access for apheresis
- Life expectancy greater than 12 weeks
- Clinician's judgment that patient can complete trial and maintain stable neurologic symptoms during treatment
You will not qualify if you...
- History of other malignancies within past 2 years except certain low-risk or treated cancers
- History of autoimmune disease or need for long-term high-dose steroids or immunosuppressive therapy
- Recent use of steroids within 7 days before apheresis or dosage not properly tapered
- Receiving other investigational agents within 14 days prior to enrollment
- Receiving chemotherapy or other anti-cancer agents within 14 days prior to apheresis
- Active infections requiring intravenous antimicrobials or invasive fungal infections
- Allergy to study products or related substances
- Uncontrolled seizures within 3 months before enrollment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
O
Ohio State University Comprehensive Cancer Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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