NCT05474378

B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Recurrent Glioblastoma Multiforme

Phase I Clinical Trial of Locoregionally (LR) Delivered Autologous B7-H3 Chimeric Antigen Receptor T Cells (B7-H3CART) in Adults With Recurrent Glioblastoma Multiforme (GBM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Brain and Nervous System

Interventions

Type	Name	Description
DRUG	B7-H3CART	B7-H3CART will be administered administered locoregionally (either ICV or both ICV and intratumorally (IT)) at one of the following doses: Dose Level -1: 5 x 10\^6 CAR+ cells (+/- 20%) Dose Level 1: 10 x 10\^6 CAR+ cells (+/- 20%) Dose Level 2: 25 x 10\^6 CAR+ cells (+/- 20%) Dose Level 3: 50 x 10\^6 CAR+ cells (+/- 20%) Dose Level 4: 100 x 10\^6 CAR+ cells (+/- 20%) B7-H3CART Dose Dose Level -1 (DL-1): 5 x 106 B7-H3CART+ cells (± 20%) Dose Level 1 (DL 1): 10 x 106 B7-H3CART+ cells (± 20%) Dose Level 2 (DL2): 25 x 106 B7-H3CART+ cells (± 20%) Dose Level 3 (DL3): 50 x 106 B7-H3CART+ cells (± 20%) Dose Level 4 (DL4): 100 x 106 B7-H3CART+ cells (± 20%) Repeated every 28 days (-7 / +14 days) as long as infusion criteria are met for a total of 6 doses, with an option for an additional 6 doses, up to a total of 12.

Timeline

• Start date: 2022-07-12
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-07-26
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study