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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

Patients are ≥ 18 years old

Capacity to understand and willingness to provide written informed consent

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Anti-GARP Chimeric Antigen Receptor-T Cells
  • Biospecimen Collection
  • Chest Radiography
  • Echocardiography Test
  • Magnetic Resonance Imaging
  • Multigated Acquisition Scan
  • Pheresis
  • Surgical Procedure

Treatment groups

30 Participants
are divided into 1 treatment group