Actively Recruiting
B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
Led by Stanford University · Updated on 2026-04-07
39
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
Sponsors
S
Stanford University
Lead Sponsor
C
California Institute for Regenerative Medicine (CIRM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, non-randomized, single site Phase I study to test the manufacturing feasibility and safety of locoregional (LR) administration of B7-H3CART into the central nervous system of adult subjects with recurrent IDH wild-type GBM using a standard 3+3 dose escalation design.
CONDITIONS
Official Title
B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years old (inclusive)
- Histologically confirmed high grade (WHO Grade IV) glioma, including glioblastoma variants, tested as IDH wild-type
- Evidence of tumor recurrence or progression by MRI after standard front-line therapy
- Resectable disease with planned surgical resection of majority of contrast-enhancing tumor
- Karnofsky Performance score of 60 or higher
- Steroid use limited to 4 mg of decadron daily or less
- Adequate organ function including: hemoglobin, ANC, platelets, lymphocyte count, creatinine, liver enzymes, bilirubin, coagulation tests, cardiac ejection fraction, and oxygen saturation within specified limits
- Willingness to use effective contraception during and for 4 months after last CAR T cell infusion
- Negative pregnancy test for females of childbearing potential
- Ability to understand and sign informed consent
- Willingness and ability to comply with study procedures and visits at Stanford Health Care
- At least 6 weeks since completion of front-line radiation therapy
- At least 3 weeks since chemotherapy or 5 half-lives since prior systemic therapy (immune checkpoint therapy requires 5 half-lives)
- At least 4 weeks from bevacizumab treatment used only for radiation necrosis or pseudo-progression
- Prior cytotoxic chemotherapy, radiation, or other anticancer therapies discontinued at least 4 weeks before treatment day 1
- Toxicities from prior therapy stable and recovered to grade 1 or less (except alopecia)
You will not qualify if you...
- Pregnant or breastfeeding patients
- Prior or current treatment with bevacizumab (Avastin) for recurrent disease (allowed for radiation necrosis)
- Prior exposure to CAR-based therapies
- Known allergy or sensitivity to study agents
- Need for anticoagulation therapy that cannot be safely paused for surgery or device access
- Prior malignancy within 3 years unless cured or prognosis good
- Significant increased intracranial pressure or uncontrolled seizures
- Uncontrolled infections requiring IV antimicrobials (simple UTI and uncomplicated pharyngitis allowed if treated)
- Known HIV or active hepatitis B or C infection; controlled hepatitis allowed
- Primary immunodeficiency or autoimmune disease causing organ injury or requiring systemic immunosuppression in last 2 years
- Significant uncontrolled medical conditions including cardiovascular, pulmonary, renal, liver, diabetes, immune-compromised states unrelated to cancer
- History of bone marrow or stem cell transplant
- Investigator judgment that participant is unlikely to complete study visits or comply with protocol requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Stanford Cancer Institute
Palo Alto, California, United States, 94305
Actively Recruiting
Research Team
K
Kelly Tanner
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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