B7-H3 CAR-T for Recurrent or Refractory Glioblastoma
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- STATUS
- Recruiting
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- End date
- Jul 1, 2024
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- participants needed
- 40
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- sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Summary
This is a randomized, parallel-arm, phase I/II study to evaluate the safety and efficacy of B7-H3 CAR-T in between Temozolomide cycles comparing to Temozolomide alone in treating patients with glioblastoma that has come back or does not respond to the standard treatment. The antigen B7-H3 is highly expressed in glioblastoma of a subset of patients. B7-H3 CAR-T, made from isolated patient peripheral blood mononuclear cells, can specifically attack patient glioblastoma cells that expressing B7-H3.
Description
Background
- B7-H3 is expressed in 70% of patients with glioblastoma
- B7-H3 is not expressed in normal tissues especially not in central nervous system. Therefore, it is an attractive GBM target for CAR-T therapy
- The investigators constructed a retroviral vector encoding a chimeric antigen receptor (CAR) targeting B7-H3, which can mediate CAR transfer into patient T cells with high efficiency.
Objectives
- To evaluate the safety and tolerability intratumoral/intracerebroventricular injection of B7-H3 CAR-T when used in between Temozolomide cycles
- To compare the overall survival (OS) and progression-free survival (PFS) of R/R GBM patients treated with B7-H3 CAR-T in between Temozolomide cycles vs Temozolomide alone
- To access the pharmacokinetics and pharmacodynamics of B7-H3 CAR-T in between Temozolomide cycles
Design
- Experimental group: Patients autologous T cells are activated and transduced with retrovirus containing B7-H3 CAR. CAR-T cells are expanded ex vivo and infused back to patients via intratumoral or intracerebroventricular injection through an Ommaya catheter. 3 injections of CAR-T are planned at two different doses with 1-2 weeks intervals. The CAR-T injections occur in between Temozolomide (TMZ) cycles. Temozolomide treatment during the cycles of CAR-T injections will be stopped and resumed next cycle. Patients may receive additional CAR-T cycles at the discretion of the principal investigator and oncologist.
- Control group: Patients will receive regular cycles of Temozolomide treatment with 5 days of treatment and 23 days of interval.
Details
| Condition | Recurrent Glioblastoma, Refractory Glioblastoma |
|---|---|
| Treatment | Temozolomide, B7-H3 CAR-T |
| Clinical Study Identifier | NCT04077866 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Last Modified on | 25 January 2021 |
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