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Immune Checkpoint Inhibitors

Enrolled patients will be administered allogeneic γδ T cells with or without the combinations of traditional therapies, including chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and others.

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.

Allogeneic γδ T cells

Weidong Han, M.D

Weidong Han

Yanshan Li

Kaichao Feng

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.

Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors

An Open-label, Phase 1/2 Study of Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors

γδ T cells in peripheral blood after infusion will be analysed by TCR or flow cytometry.

The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.

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.

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.

The duration of objective response in patients will be recorded until 2years after the start of 1st cycle of treatment

Observation for overall survival l (OS) will be recorded until 2years after the start of 1st cycle of treatment.

Observation for progression-free survival (PFS) will be recorded until 2years after the start of 1st cycle of treatment

Incidence, nature ,and severity of adverse events will be graded according to the NCI CTCAEv5.0.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors	NCT04765462	Malignant Solid...	Allogeneic γδ T...	18 Years - 75 Years	Chinese PLA General Hospital
Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors	NCT04765462	Malignant Solid...	Allogeneic γδ T...	18 Years - 75 Years	Chinese PLA General Hospital

Spots Global Cancer Trial Database for allogeneic γδ t cells