RecruitingPhase 1NCT05474378

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)


Sponsor

Stanford University

Enrollment

39 participants

Start Date

Jul 12, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing B7-H3 CAR-T cell therapy — immune cells engineered to attack a specific protein found on brain tumor cells — in patients with recurrent glioblastoma, the most aggressive type of brain tumor, that has come back after initial treatment. **You may be eligible if...** - You are 18–75 years old and have been diagnosed with WHO Grade IV glioma (glioblastoma), confirmed as IDH wild-type - Your tumor has come back after standard treatment (first recurrence) and surgery is being considered - You have adequate blood counts, kidney, liver, and heart function - Your overall condition allows for surgery (Karnofsky Performance Score ≥ 60) **You may NOT be eligible if...** - Your tumor is in its first occurrence (not yet recurrent) - You have significant organ dysfunction (heart, liver, kidneys) - You are on high doses of steroids (more than 4 mg decadron per day) - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGB7-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.


Locations(1)

Stanford Cancer Institute

Palo Alto, California, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05474378


Related Trials