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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06964737
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Malignant Glioma
  • Recurrent WHO Grade 3 Glioma
  • Recurrent WHO Grade 4 Glioma
  • WHO Grade 2 Glioma
  • WHO Grade 3 Glioma
  • WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anti-GARP Chimeric Antigen Receptor-T Cells — BIOLOGICAL
    Given intracavitary
  • Biospecimen Collection — PROCEDURE
    Undergo collection of CSF and blood samples
  • Chest Radiography — PROCEDURE
    Undergo chest x-ray
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Surgical Procedure — PROCEDURE
    Undergo surgery and placement of CSF reservoir

Study Details

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.

Key Dates

Start date
May 21, 2025
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
James B. Elder, MD
[email protected]
614-685-1965
James B. Elder, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Columbus, OH

By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

Related Studies