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| Name | Class |
|---|---|
| Eastern Hepatobiliary Surgery Hospital | 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 or biopsies 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 | 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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| Arm A | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC203 TIL(gene-edited TIL) or autologous TILs | Biological | the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To characterize the safety profile of TILs in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events. | 6 months |
| 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) | Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GC Clinical | Contact | 086-18001759113 | clinicaltrials@juncell.com |
| Name | Affiliation | Role |
|---|---|---|
| Qian Zhang | Eastern Hepatobiliary Surgery Hospital | Principal Investigator |
| Wenlong Yu | Eastern Hepatobiliary Surgery Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Naval Medical University | Recruiting | Shanghai | 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 length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1 | Up to 36 months |