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| Name | Class |
|---|---|
| Shanghai 10th People's Hospital | OTHER |
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This study is to investigate the safety and efficacy of signal switch receptor modified TIL (GC201 TIL) in patients with advanced gynecologic tumors. Autologous TILs from tumor resections or biopsies are first gene modified(TGF-β receptor or PD-1 gene modified TILs which could transfer the suppression signal surrounding the microenvironment of tumor bed into persistent T cell activation signal) and than expanded before i.v. infusion into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Signal Switch Receptor Modified TIL | Experimental | 2x10^8-1x10^10 in vitro expanded autologous PD-1 or TGF-β signal switch receptor modified TIL (GC201 TIL) will be infused i.v. to patients with advanced gynecologic tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Signal Switch Receptor Modified TIL | Biological | Adoptive transfer of 2x10^8-1x10^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AE) | To characterize the safety profile of Signal Switch Receptor Modified TIL (GC201 TIL) in patients with advanced gynecologic tumors as assessed by incidence of adverse events related to GC201 TIL infusion. | Up to 6 months |
| 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 TIL infusion,PET/CT scan will be performed at 6 weeks after GC201 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 |
| 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) | 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 GC201 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 GC201 TIL treatment that the patients are still alive |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life | Comparison of patients' quality of life before and after GC201 TIL treatment as assessed by the EORTC QLQ-30 (V3.0). | Up to 36 months |
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Inclusion Criteria:
Age: 18 years to 75 years;
Histologically diagnosed as primary/relapsed/metastasized Gynecological 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 | |
|---|---|---|---|---|
| Clinical GC | Contact | 086-18001759113 | clinicaltrials@juncell.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tenth People's Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| Up to 36 months ] |