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| Name | Class |
|---|---|
| Sichuan Cancer Hospital and Research Institute | OTHER |
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This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm B | Experimental | GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
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| Arm A | Experimental | GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC101TIL | Biological | A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma 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 |
| Name | Affiliation | Role |
|---|---|---|
| Huangming Hong | Sichuan Cancer Hospital & Institute, Sichuan Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Cancer Hospital & Institute, Sichuan Cancer Center | Chengdu | China |
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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 |