The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.
This is an open-label, single-center, phase 1/2 study to evaluate the safety, feasibility and efficacy of allogeneic γδ T cell therapy. In phase 1 period, a typical 3+3 dose-escalation design will be used to determine the optimal dose level based on the incidence of dose-limiting toxicity (DLT), which will be recommended as the fixed dose level in the following expansion period and phase 2. The initial infusion dose level will start from 2x10\^6/kg to 5x10\^7/kg in every 2-4 weeks. Combinations with chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and other therapies are allowed in this study depending on the disease status of the enrolled patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Phase 1:Enrolled patents will be administered allogeneic γδ T cells from 2x10\^6/kg, 1 x10\^7/kg to 5x10\^7/kg every 2-4 weeks to determine the recommended dose level. Phase 2: Enrolled patents will be administered allogeneic γδ T cells at the recommended dose level to confirm the efficacy. Whether or not in combination with other therapies will be determined by research physicians according to the disease status of enrolled patients.
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China
RECRUITINGIncidence of dose-limiting toxicity (DLT)
The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.
Time frame: Baseline to Day 30
Incidence of severe adverse events
Safety of the γδ T cell infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Time frame: Baseline to Day 100
Objective Response Rate
Objective clinical response will be assessed by investigators every 2 circles during the treatments and every 2 months after treatment until 2 years after the start of 1st cycle of treatment.
Time frame: Baseline to 2years
Duration of Response
The duration of objective response in patients will be recorded until 2years after the start of 1st cycle of treatment
Time frame: Baseline to 2years
Overall Survival
Observation for overall survival l (OS) will be recorded until 2years after the start of 1st cycle of treatment.
Time frame: Baseline to 2years
Progress Free Survival
Observation for progression-free survival (PFS) will be recorded until 2years after the start of 1st cycle of treatment
Time frame: Baseline to 2years
Intervention Treatment-related adverse events(AEs)
Incidence, nature ,and severity of adverse events will be graded according to the NCI CTCAEv5.0.
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Time frame: Baseline to 12 months