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.
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
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
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.
Recurrent Glioblastoma, Refractory Glioblastoma
Clinical Study Identifier
Second Affiliated Hospital, School of Medicine, Zhejiang University
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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