Targeting TGFβ docking receptor glycoprotein A repetitions predominant (GARP) via novel chimeric antigen receptor (CAR)-T cell platform to treat glioblastoma.
Bill Xingjun Wu, Daniel Kreatsoulas, Hakan Cam...
https://pubmed.ncbi.nlm.nih.gov/40873341Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID06964737
A Phase I, Dose-Escalation Trial of Anti-GARP CAR T Cell Therapy for Recurrent High-Grade Glioma at a Single Medical Center
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called anti-GARP chimeric antigen receptor (CAR) T cell therapy for patients with recurrent grade III or IV gliomas, which are high-grade brain tumors that have returned after initial improvement. This phase I trial aims to assess the safety, side effects, and best dose of this therapy. CAR T-cell therapy involves modifying a patient's immune cells to better attack tumor cells. The study also plans to explore how the therapy affects the immune response and tumor activity over time, including survival outcomes and tumor marker expression. Participants undergo a series of procedures starting with apheresis to collect their T cells, followed by surgery to place a cerebrospinal fluid (CSF) reservoir. The modified anti-GARP CAR T cells are then infused directly into the brain cavity on days 14, 21, 28, 35, and 42 if the disease does not progress or unacceptable side effects occur. Throughout the study, patients receive various scans and tests such as echocardiography or MUGA, chest x-rays, MRI scans, lumbar punctures, and blood and CSF sample collections to monitor safety and treatment effects. During the trial, participants will be closely monitored for dose-limiting toxicities up to 30 days after the first dose. Adverse events, immune cell characteristics, cytokine levels, tumor responses by imaging, progression-free and overall survival will be tracked for up to 15 years. Follow-up visits occur frequently in the first months and then annually for at least 15 years. This long-term monitoring helps researchers understand the therapy's lasting effects and safety.
CONDITIONS
Brief Title
Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients are 18 years old or older
- Capacity to understand and provide written informed consent
- Diagnosis or clinical suspicion of recurrent malignant glioma (WHO grade III or IV) or prior grade II glioma with new findings
- Imaging or biopsy confirmation of recurrent disease with measurable tumor by RANO criteria
- Unifocal disease in one brain hemisphere, not in critical brain areas
- If on steroids, must be low dose (4 mg/day or less) and stable before treatment
- No prior or planned bevacizumab therapy
- Karnofsky performance score 60 or higher
- Candidate for surgery with intent to resect over 80-90% of tumor
- White blood cells above 4,000 cells/uL
- Hemoglobin above 7 gm/dL
- Platelets above 100/dL
- Kidney and liver function within 1.5 times normal limits
- Negative pregnancy test for women of reproductive potential
- Use of approved contraceptives and refraining from sperm donation during and after treatment
- Sufficient venous access for apheresis
- Life expectancy greater than 12 weeks
- Clinical judgement of ability to complete trial and maintain stable neurological symptoms
You will not qualify if you...
- History of other malignancies except certain treated cancers without relapse
- History of autoimmune disease or need for high-dose steroids or immunosuppressives
- Concurrent treatment with other investigational agents
- Recent chemotherapy or other anti-cancer treatments within 14 days before apheresis
- Active infections requiring IV antimicrobials or invasive fungal infections
- Allergy to study products or components
- Uncontrolled seizures within the last 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
. Participants undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) and other assessments during screening.
Run-in Period
Duration - Approximately 2 weeks before surgery
Participants undergo apheresis to collect cells before surgery.
1 visit for apheresis
Surgery
Duration - 1 day
Participants undergo surgery for tumor resection and placement of a cerebrospinal fluid (CSF) reservoir.
1 surgical procedure visit (in-person)
Treatment
Duration - From Day 14 to Day 42
Participants receive anti-GARP CAR T cell therapy via intracavitary infusions on multiple days if there is no disease progression or unacceptable toxicity.
5 intracavitary infusion visits on Days 14, 21, 28, 35, and 42
Post-operative Follow-up
Duration - Up to 15 years
Participants have regular assessments including collection of cerebrospinal fluid (CSF) and blood samples, lumbar punctures, chest x-rays, and magnetic resonance imaging (MRI) to monitor safety and response.
Follow-up visits at 2 weeks, then at 3, 4, 6, 8, 12, and 24 months, then annually for at least 15 years
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
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Research Team
O
Ohio State University Comprehensive Cancer Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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