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The study was terminated from a business perspective.
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This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.
An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GT201 treatment group | Experimental | Autologous tumor infiltrating lymphocyte injection |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GT201 | Biological | Autologous tumor infiltrating lymphocyte injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adcersed events per CTCAE 5.0 | To characterize the safety profile of autologous TIL injection(GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0 | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator | 3 years |
| Progression-free survival | To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator |
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Inclusion Criteria:
Exclusion Criteria:
7:Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Zhejiang University | Hangzhou | Zhejiang | China |
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| 3 years |
| Overall survival | To evaluate efficacy parameters such Overall Survival (OS) | 3 years |