This study intends to combine the advantages of γδ T cells and PD-1 monoclonal antibody to conduct an exploratory clinical study on the safety and efficacy of PD-1 antibody armored γδ T cells (γδ T-PD-1 Ab cells) in the treatment of malignant meningioma.
This is a single-center, single-arm, phase I clinical trial to evaluate the safety and efficacy of γδ T-PD-1 Ab cells in patients with malignant meningioma. A typical 3+3 dose-escalation design will be used to determine the optimal dose level of γδ T-PD-1 Ab cells based on the incidence of dose-limiting toxicity (DLT). The initial injection dose level will start from 1×10\^7 to 1×10\^8 in every 2 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Patients will receive 6 cycles of ex-vivo expanded γδ T-PD-1 Ab cells treatments,at two-weeks' intervals.γδ T-PD-1 Ab cells are injected through the Ommaya device in a typical 3+3 dose-escalation design(Dose escalation, 1×10\^7, 3×10\^7, 1×10\^8).
Safety evaluation: Incidence of Adverse events (AEs)
Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Time frame: 96 weeks
Safety evaluation: Dose limited toxicity (DLTs)
The incidence, characteristic and severity of DLTs will be recorded and assessed.
Time frame: 96 weeks
Safety evaluation: Maximum-tolerated dose (MTD)
MTD or clinical recommended dose will be recorded and evaluated.
Time frame: 96 weeks
Efficacy evaluation: Objective Response Rate(ORR)
Objective response rate will be assessed by investigators.
Time frame: 12 weeks
Efficacy evaluation: Disease Control Rate (DCR)
Disease Control Rate will be assessed by investigators.
Time frame: 12 weeks
Efficacy evaluation: Progress Free Survival(PFS)
Observation for progression-free survival (PFS) will be recorded until 6 months after the start of 1st cycle of treatment.
Time frame: 12 weeks
Efficacy evaluation: Two-year Overall Survival Rate (OS)
Observation for overall survival (OS) will be recorded until 24months after the start of 1st cycle of treatment.
Time frame: 96 weeks
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