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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic γδ T cell Group | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic γδ T cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence 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. | 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. | Baseline to Day 100 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 2years |
| Duration of Response |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory research | γδ T cells in peripheral blood after infusion will be analysed by TCR or flow cytometry. | Baseline to 12 months |
Inclusion Criteria:
Exclusion Criteria:
Donor Inclusion Criteria:
Donor Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weidong Han, M.D | Contact | +8601066937463 | hanwdrsw69@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Weidong Han, M.D | Biotherapeutic Department of Chinese PLA General Hospital | Principal Investigator |
| Yanshan Li | Biotherapeutic Department of Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotherapeutic Department of Chinsese PLA Gereral Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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The duration of objective response in patients will be recorded until 2years after the start of 1st cycle of treatment |
| Baseline to 2years |
| Overall Survival | Observation for overall survival l (OS) will be recorded until 2years after the start of 1st cycle of treatment. | 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 | 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. | Baseline to 12 months |
| Kaichao Feng | Biotherapeutic Department of Chinese PLA General Hospital | Principal Investigator |