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| Name | Class |
|---|---|
| Shanghai Tong Ren 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 malignant solid tumors.Autologous 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 |
|---|---|---|---|
| Tumor Infiltrating Lymphocytes | Experimental | 1x10^9-5x10^10 in vitro expanded autologous TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Infiltrating Lymphocytes (TIL) | Biological | Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10^9-5x10^10 autologous TILs to patients i.v. in 30-120 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events(AE) | To characterize the safety profile of GC101 TIL in patients with recurrent, metastatic, or persistent solid tumor as assessed by incidence of adverse events. | 6 month |
| Objective Response Rate (ORR) | Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1): ORR (proportion of patients) = # with CR + # with PR / # with CR + # with PR + # with SD + # with PD. ( Except baseline evaluation within 28 days before GC101 TIL infusion,PET/CT scan will be performed at 6 weeks after TIL infusion, and than every 6 weeks for 6 months, and then every 6 months after that for up to 3 years) | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) | Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST v1.1: DCR (proportion of patients) = # with CR + # with PR + # with SD / # with CR + # with PR + # with SD + # with PD. | Up to 36 months |
| Duration of Response (DOR) |
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Inclusion Criteria:
Age: 18 years to 75 years;
Histologically diagnosed as primary/relapsed/metastasized malignant tumors;
Expected life-span more than 3 months;
Karnofsky≥60% or ECOG score 0-2;
Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available.
Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated;
At least 1 evaluable tumor lesion;
Hematology and Chemistry(within 7 days prior to enrollment):
No absolute or relative contraindications to operation or biopsy;
Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent, and continue within 1 year after the completion of lymphodepletionï¼›
Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy and biologics must cease 28 days before obtaining TILs;
Be able to understand and sign the informed consent document;
Be able to stick to follow-up visit plan and other requirements in the agreement.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GC Clinical | Contact | +86-18001759113 | clinicaltrials@juncell.com |
| Name | Affiliation | Role |
|---|---|---|
| LiJun Ma | Shanghai Tong Ren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongren Hospital Shanghai Jiao Tong University School Of Medicine. | Recruiting | Shanghai | China |
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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 GC101 TIL infusion and confirmed subsequent disease progression according to RECIST 1.1 | Up to 36 months |
| Overall Survival (OS) | The length of time from the date of the start of GC101-TIL treatment that the patients are still alive. | Up to 36 months |