Status:
RECRUITING
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Recurrent Malignant Glioma
Recurrent WHO Grade 3 Glioma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Detailed Description
PRIMARY OBJECTIVE: I. To assess the safety and feasibility of a CAR T targeting GARP for glioma by defining rate, frequency, and severity of dose limiting toxicities (DLT) following intracavity admin...
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
- Disease in one hemisphere and is supratentorial
- 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
- Subjects must not have received bevacizumab therapy and are not planned to start such therapy
- Karnofsky performance score (KPS) ≥ 60
- Surgical candidate for surgery for malignant glioma
- 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
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
Key Trial Info
Start Date :
May 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06964737
Start Date
May 21 2025
End Date
December 31 2026
Last Update
October 29 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210