CAR.B7-H3T Cells for Recurrent or Refractory Glioblastoma
This study is testing the safety of a new treatment called CAR.B7-H3T cells for people with glioblastoma multiforme (GBM), a type of brain cancer, that has come back or is not responding to other treatments. CAR.B7-H3T cells are a type of immunotherapy where your own immune cells are specially trained to fight cancer. These cells will be given directly into the fluid around your brain (intraventricular infusion) up to three times. This is the first time CAR.B7-H3T cells are being tested in humans for GBM. To join, you must be an adult with recurrent or refractory GBM and have a Karnofsky score (a measure of your ability to perform daily activities) above 60%. The main goal is to see how safe this treatment is by tracking side effects like adverse events, cytokine release syndrome, and neurotoxicity for up to 10 weeks.
- Study design
- This is a Phase 1, single-center study that is open-label, meaning both you and the study team will know what treatment you are receiving. It plans to enroll 36 participants to determine the safest dose.
- What's involved
- If you are eligible, your cells will be collected after surgery to create the CAR.B7-H3T cells. You would then receive up to three weekly infusions of these cells, each lasting 5-10 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 10 weeks after treatment to track any adverse events, cytokine release syndrome, or neurotoxicity.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Felicia Cao, MD, PhD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center
Who to contact
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What this trial measures
- Number of participants with adverse eventUp to 10 weeks
Number of participants with adverse event (AE)s as a measure of safety and tolerability of intraventricular administration CAR.B7-H3 T cells in subjects with progressive recurrent or refractory glioblastoma multiforme. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Dose Limiting Toxicities (DLTs) are defined as at least possibly related to CAR.B7-H3T cell product administration.
- Cytokine Release SyndromeUp to 10 weeks
Cytokine Release Syndrome (CRS) will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38\^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin),Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
- NeurotoxicityUp to 10 weeks
Neurotoxicity will be graded according to the Central Nervous System (CNS) Toxicity criteria. Grade 0: Normal or no change from baseline exam at start of therapy, Grade 1: Mild lethargy and/or irritability or visual, motor, or sensory symptoms without change in neurological exam, Grade 2: Moderate lethargy, disorientation, or psychosis lasting \< 48 hours or mild increase in pre-existing neurological deficit, Grade 3: \>48hours of severe lethargy, but responsive to verbal stimuli or disorientation or psychosis lasting \>48 hours, Grade 4: Coma, unresponsive to verbal stimuli, increasing neurological deficit above grade 3, evidence of herniation, development of uncontrolled seizures, intracerebral hemorrhage.