Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas

Recruiting now · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID: NCT06964737
Run by: Ohio State University Comprehensive Cancer Center
People needed: 30
Starts: 2025-05-21
Expected to finish: 2027-05-31
Last updated by the study team: 2026-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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) > 100/dL
Serum creatinine ≤ 1.5 x institutional upper limit of normal
Liver function tests within 1.5 x institutional upper limit of normal
Women of reproductive potential must have a negative pregnancy test within 7 days of study start. All patients of reproductive potential must use a physician-approved contraceptive and refrain from sperm donation for at least two weeks prior, during, and six months after final T cell infusion. Women must refrain from breastfeeding for six months after final T cell infusion
Sufficient venous access, to be confirmed prior to apheresis
Life expectancy of greater than 12 weeks
PI clinical judgement of patients who will likely complete the trial and are able to maintain stable neurologic symptoms during intervention period

You may not qualify if…

Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following malignancies/treatment characteristics, who are eligible at the investigator's discretion:
Patients with a history of malignancy that has been treated with curative intent at least 2 years prior to screening and with no evidence of relapse, if no concurrent anti-cancer therapy (except hormonal therapy) is being given
Patients with a history of malignancy with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer
Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy
History of autoimmune disease, or other diseases require long-term administration of high-dose steroids [> 10 mgs/day] or immunosuppressive therapies
Research participants who received steroids must have either received their last dose of steroids 7 days or more prior to apheresis or have dosage tapered to < 2mg/kg/day
Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent
Examples of other investigational agents that would be exclusionary include supportive care agents
Patients receiving anti-cancer agents such as chemotherapy (e.g., temozolomide) must stop treatment 14 days prior to undergoing apheresis and remain off therapy throughout the duration of CAR T therapeutic intervention
Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials
Prophylactic antimicrobials are allowed
Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials
History of allergy to study products/diluents/emulsions
Recent history (within last 3 months) of uncontrolled seizures

Where it is running

Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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