Recruiting
Phase 1

Anti-GARP CAR T Cell Therapy

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06964737

Conditions

Recurrent Malignant Glioma

Recurrent WHO Grade 3 Glioma

Recurrent WHO Grade 4 Glioma

WHO Grade 2 Glioma

WHO Grade 3 Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Anti-GARP Chimeric Antigen Receptor-T Cells

Biospecimen Collection

Chest Radiography

Echocardiography Test

Magnetic Resonance Imaging

Study Details

Brief 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

Study ID

NCT06964737

Start date

May 21, 2025

Status verified date

Oct, 2025

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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) > 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 Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (anti-GARP CAR T cell)

Patients undergo apheresis on day -14 and undergo surgery and placement of CSF reservoir on day 0. Patients receive anti-GARP CAR T intracavitary infusion on day 14, 21, 28, 35 and 42 in the absence of disease progression or unacceptable toxicities. Additionally, patients undergo ECHO or MUGA at screening and collection of CSF and blood samples, lumbar puncture, chest x-ray and MRI throughout the study.

Interventions

Anti-GARP Chimeric Antigen Receptor-T Cells

Given intracavitary

Biospecimen Collection

Undergo collection of CSF and blood samples

Chest Radiography

Undergo chest x-ray

Echocardiography Test

Undergo ECHO

Magnetic Resonance Imaging

Undergo MRI

Multigated Acquisition Scan

Undergo MUGA

Pheresis

Undergo apheresis

Surgical Procedure

Undergo surgery and placement of CSF reservoir

Primary outcome measure

  • Dose limiting toxicities [ Time Frame: Up to 30 days after the first dose ]

Central Contacts and Locations

Central contacts

Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCclinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

James B. Elder, MD

614-685-1965brad.elder@osumc.edu

Principal Investigator:

James B. Elder, MD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

May 8, 2026

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-05-08.