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

Launched by OHIO STATE UNIVERSITY COMPREHENSIVE CANCER CENTER · May 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new type of treatment called anti-GARP CAR T cell therapy for patients who have recurrent grade III or IV gliomas, which are serious brain tumors that have returned after previous treatment. CAR T cell therapy works by taking a patient's immune cells, called T cells, and modifying them in a lab to better target and attack tumor cells. The goal of this trial is to find out how safe this new treatment is, any side effects it might cause, and how well it works for these patients.

To participate in the trial, patients need to be at least 18 years old and have a diagnosis of recurrent malignant glioma. They should be able to understand the study and give written consent. Other important criteria include having measurable disease confirmed by imaging or biopsy and having certain health requirements, like a specific level of blood cells. Participants can expect to undergo a process where their T cells are collected, modified, and then infused back into their body to help fight the tumor. This trial is currently not recruiting participants, but it offers hope for new treatment options for those with challenging brain tumors.

Gender

ALL

Eligibility criteria

• 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
• • 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 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