Allogeneic B7-H3 CAR-B3B4T Cell Therapy for Recurrent or Progressive High-Grade Glioma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a new cell therapy using allogeneic B7-H3 CAR gamma delta T cells in patients with malignant brain gliomas, including high-grade gliomas and glioblastoma multiforme (GBM). This therapy targets the B7-H3 protein, which is found at high levels on tumor cells and tumor-associated blood vessels, making it a promising target for immunotherapy. The study is conducted as an open-label, single-arm trial with dose-escalation and dose-expansion phases. Participants receive the investigational cell therapy, called QH104, administered through an Ommaya reservoir or intrathecal injection. The study includes a dose-escalation phase with three different dose levels given once every four weeks. Following this, there are two dose expansion phases: one with the recommended phase 2 dose given every four weeks, and another with a fixed dose given every two weeks for three months, then every four weeks thereafter. This schedule aims to assess the optimal dosing and safety of the therapy. During the study, participants will be closely monitored for adverse events, dose-limiting toxicities, and maximum tolerated dose within the first 28 days, with safety followed for up to 12 months. Researchers will measure the number of CAR T cells in cerebrospinal fluid, cytokine levels, overall survival, progression-free survival, and disease control rate over several months. Regular assessments, laboratory tests, imaging, and evaluations of neurological function will help track participants' responses and safety throughout the trial period.

Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection