Pilot Study of B7-H3 CAR-T in Treating Patients With Recurrent and Refractory Glioblastoma

  • STATUS
    Recruiting
  • participants needed
    12
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 9 August 2022
serum pregnancy test
international normalized ratio
neutrophil count
immunohistochemistry
bevacizumab
aptt
recurrent disease
glioblastoma multiforme
temozolomide

Summary

This is a pilot phase I study to evaluate the safety and efficacy on B7-H3 CAR-T in between Temozolomide cycles 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 to the historical Temozolomide data
  • To access the pharmacokinetics and pharmacodynamics of B7-H3 CAR-T in between Temozolomide cycles

Design

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 in the cycle 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.

Details
Condition Recurrent Glioblastoma, Refractory Glioblastoma
Treatment Temozolomide, B7-H3 CAR-T
Clinical Study IdentifierNCT04385173
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on9 August 2022

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