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New treatment option for Brain and Nervous System
Official title B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
ClinicalTrials.gov ID: NCT05474378
What this study is testing
What is B7-H3CART?
B7-H3CART is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain and nervous system.
Also referred to as B7H3-CAR T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed high grade (WHO Grade IV) glioma including but not limited to glioblastoma, gliosarcoma, glioblastoma with oligodendroglial...
- 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...
- 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.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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...
- 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:
- Hgb ≥ 12 g/dL (male) or ≥ 11.5 g/dL (females)
- ANC ≥ 1500/uL
- Platelets ≥ 100,000/uL
- Absolute lymphocyte count ≥150/uL
- Serum Creatinine ≤ 1.5mg/dl; Cr clearance should be ≥ 50 mL/min
- Serum AST and ALT ≤ 3x ULN (Grade 1)
- Total Bilirubin ≤ 1.5 X ULN
- PT or PTT ≤ 1.25 X ULN
- Cardiac ejection fraction ≥45% without signs of physiologically significant pericardial effusion or clinically significant ECG findings.
- Baseline oxygen saturation \> 92% on room air
- people 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...
- All female people 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...
- 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).
- 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...
- 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...
- 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...
- Significant medical diseases or conditions, including poorly controlled conditions: i.e. hypertension, cardiovascular disease, diabetes mellitus, chronic obstructive pulmonary disease, pulmonary fibrosis, inflammatory...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.