Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV… (NCT06964737) | Clinical Trial Compass
RecruitingPhase 1
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
United States30 participantsStarted 2025-05-21
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients are ≥ 18 years old
* Capacity to understand and willingness to provide written informed consent
* Diagnosis or clinical suspicion of recurrent malignant glioma, including:
* History of high-grade glioma (World Health Organization \[WHO\] grade III or IV), or
* Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma
* Imaging and/or histopathological confirmation of recurrent disease, or verification of "high risk" histology confirmed by a biopsy with measurable disease by the Radiologic Assessment in Neuro-Oncology (RANO) criteria
* Patient has unifocal disease in one hemisphere and is supratentorial. Lesion and edema can not be located in eloquent locations (e.g., brainstem, pre-/post-central gyrus, visual cortex) or within 2 gyri of motor strip.
* If on steroids such as dexamethasone, must be on a low dose (≤ 4mg per day) at the time of treatment, and not at an ascending dosage schedule at time of enrollment/leukapheresis
* Prior to apheresis and treatment 1 a 2- week washout should be observed
* Subjects must not have received bevacizumab therapy and are not planned to start such therapy
* Karnofsky performance score (KPS) ≥ 60
* Subject is a surgical candidate for surgery for malignant glioma with the intent of resecting \>80-90% of the tumor as the ideal treatment option
* White blood cells (WBC) \> 4,000 cells/uL
* Hemoglobin (Hgb) \> 7 gm/dL
* Platelets (Plt)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial primarily designed to find a safe dose of anti-GARP CAR T cells rather than to prove the treatment works, what does that mean for what we actually know so far about its risks and benefits for someone with my grade of glioma?
2The trial is specifically looking at dose-limiting toxicities — what kinds of side effects are they watching for with this CAR T cell approach, and how would those be managed if they occurred?
3My tumor is classified as recurrent WHO Grade 3 or 4 glioma — given where I am in my treatment history, would standard re-treatment options or other trials be worth comparing to this one before deciding anything?
4CAR T cell therapy can sometimes cause serious immune reactions — given that this is targeting a protein called GARP in a brain tumor, are there any specific risks related to the brain or nervous system that I should understand before considering this?
5What would participating in this trial actually look like day-to-day — how many visits, how long, and what happens to my care if I experience a serious side effect or the tumor progresses while I'm enrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose limiting toxicities
Timeframe: Up to 30 days after the first dose
Trial details
NCT IDNCT06964737
SponsorOhio State University Comprehensive Cancer Center