B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme
ConditionBrain and Nervous System
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorStanford University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- B7-H3CART
Treatment groups
39 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stanford University
Lead sponsor
California Institute for Regenerative Medicine (CIRM)
Collaborator
Parker Institute for Cancer Immunotherapy
Collaborator
Source ClinicalTrials.gov