Anti-GARP CAR T-Cell Therapy for Recurrent Gliomas
This study is testing a new treatment called Anti-GARP Chimeric Antigen Receptor (CAR) T-cell therapy for people with grade III or IV gliomas (a type of brain tumor) that have returned. CAR T-cell therapy involves taking your own immune cells (T cells), modifying them in the lab to recognize and attack tumor cells that have a protein called GARP, and then giving them back to you. The main goal is to see if this treatment is safe and what side effects it might have, especially within 30 days after the first dose. Researchers also want to find the best dose and see how well it works against the tumor. This study is for adults aged 18 and older who have a diagnosis or strong suspicion of recurrent malignant glioma.
- Study design
- This is an interventional study with a planned enrollment of 30 participants. It is designed to evaluate the safety and feasibility of the treatment.
- What's involved
- You would undergo biospecimen collection (blood and CSF samples), chest x-rays, echocardiograms, and MRIs. The Anti-GARP CAR T-cells are given intracavitary (directly into the tumor area).
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoint is measured up to 30 days after the first dose. The record does not specify the full duration of follow-up after this period.
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NCT06964737
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
Recruiting
PHASE1Ages 18+InterventionalTreatmentOhio State University Comprehensive Cancer CenterInvestigator-initiated
~30 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:Anti-GARP Chimeric Antigen Receptor-T CellsBiospecimen CollectionChest RadiographyEchocardiography TestMagnetic Resonance ImagingMultigated Acquisition Scan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicities
Measured over Up to 30 days after the first dose
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- James B Elder, MD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
Exclusion
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
What this trial measures
- Dose limiting toxicitiesUp to 30 days after the first dose
The rate, frequency and severity will be defined using Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. Will be summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.