B7-H3CART for Recurrent Glioblastoma Multiforme
This study is testing a treatment called B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) for adults with glioblastoma (a type of brain cancer) that has returned or worsened after standard treatments. B7-H3CART is a type of CAR T-cell therapy, which uses your own immune cells to fight cancer. The treatment will be given directly into the brain (locoregionally) at different dose levels to see what dose is safest and most effective. The main goals are to see if the B7-H3CART can be successfully made and to find the highest safe dose. You may be able to join if you are an adult with recurrent glioblastoma that meets specific criteria. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase 1, open-label study, meaning you and your doctors will know what treatment you are receiving. It is not randomized and will involve about 39 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track the success of manufacturing the treatment and the maximum tolerated dose for up to 5 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05474378
B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
Recruiting
PHASE1Ages 18+InterventionalTreatmentStanford UniversityInvestigator-initiated
~39 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:B7-H3CART
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range
Measured over 5 years
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Reena Thomas, MD, PhD · PRINCIPAL_INVESTIGATOR · Stanford University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Histologically confirmed high grade (WHO Grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial features, glioblastoma with PNET features, tested as IDH wild-type, as per revised WHO 2021 criteria. Patients must also have evidence of tumor recurrence/progression by MRI (RANO criteria) after standard front-line therapy. b. First recurrence or progressive disease after a standard line therapy.
Resectable disease: Resection is being considered as part of the standard of care for the patient and it is thought that it is feasible that a majority of contrast-enhancing tumor mass/signal can be resected.
Patients must be between the ages of 18 and 75 years old (inclusive).
Karnofsky Performance score ≥ 60.
Use of steroids must be limited to ≤ 4 mg of decadron daily.
Adequate organ function at time of screening visit including:
Subjects of child-bearing or child-fathering potential must be willing to use an effective method of contraception (hormonal or two barrier methods) while on study and for at least 4 months following the last CAR T cell infusion or as long as B7-H3CART are detectable in peripheral blood or CSF.
All female subjects of childbearing age must have a negative blood or urine pregnancy test.
Ability to understand and willingness to sign a written informed consent document.
Must be willing and able to comply with procedures, return visits and evaluations at Stanford Health Care while on this protocol.
Prior Therapy:
At least 6 weeks following completion of front-line radiation therapy.
At least 3 weeks post chemotherapy or 5 half-lives, whichever is shorter must have elapsed since any prior systemic therapy, except for systemic inhibitory/stimulatory immune checkpoint therapy, which requires 5 half-lives.
At least 4 weeks from bevacizumab treatment, which can be used only for radiation necrosis or pseudo-progression.
Prior cytotoxic chemotherapy, radiation, or other anticancer therapies including investigational agents discontinued at least 4 weeks prior to Day 1 of treatment.
Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia).
Exclusion
Pregnant or patients who are breastfeeding.
Prior or concurrent treatment with Avastin (bevacizumab) for the purposes of recurrent disease. Avastin (bevacizumab) may have been used for radiation necrosis.
Prior exposure to chimeric antigen receptor (CAR) based therapies.
Known sensitivity or allergy to any agents/reagents used in this study.
Requires current anticoagulation therapy that cannot be safely paused for surgical resection and Ommaya access.
Prior malignancy except previously diagnosed and definitively treated more than 3 years prior to trial or whose prognosis is deemed good enough to not warrant surveillance.
Clinical evidence of significant increased intracranial pressure (i.e. impending herniation) or uncontrolled seizures.
Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. Simple UTI and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and/or nucleic acid testing.
Primary immunodeficiency or history of autoimmune disease (e.g. Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
Significant medical diseases or conditions, including poorly controlled conditions: i.e. hypertension, cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, pulmonary fibrosis, inflammatory disorders, immunodeficiency (e.g., HIV infection), immune compromised for reasons other than malignancy (e.g., chronic corticosteroid therapy or other immunosuppressive therapy), renal failure including patients requiring dialysis, liver dysfunction, second malignancy (except treated basal cell or localized squamous cell skin carcinomas), or active infection.
History of bone marrow or stem cell transplantation.
In the investigator's judgment, the subject is unlikely to complete all protocol- required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
What this trial measures
- Number of successful manufacturing product (B7-H3CART) that met minimum assigned dose level range5 years
Defined by the frequency of successful manufacturing runs of B7-H3CART that meet the established IND release criteria for the targeted dose level.
- Maximum Tolerated Dose (MTD) or Recommended phase 2 dose (RP2D)5 years
Defined by the frequency of subjects experiencing dose limiting toxicity (DLT) after initial infusion