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| Name | Class |
|---|---|
| Shenzhen Hospital of Southern Medical University | OTHER |
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This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GC203 TIL | Experimental | participants with advanced solid tumors using cryopreserved GC203 TIL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC203 TIL | Biological | A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) | Up to 36 months |
| Disease Control Rate (DCR) | Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Cheng | Contact | +8621-69110327 | ying.cheng@juncell.com |
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| Up to 36 months |
| Duration of Response (DOR) | The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1 | Up to 36 months |
| Progression-Free Survival (PFS) | The time from TIL infusion until disease progression or death from any cause. | Up to 36 months |
| Overall Survival(OS) | The time from TIL infusion until death from any cause. | Up to 36 months |