A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)
NCT05098171 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2025-12-11
Summary
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.
Conditions
- Advanced Gynecologic Tumors
- Signal Switch Receptor Modified TIL
- Treatment Side Effects
- Effects of Immunotherapy
Interventions
- BIOLOGICAL
-
Signal Switch Receptor Modified TIL
Adoptive transfer of 2x10\^8-1x10\^10 autologous signal switch receptor modified TILs to patients i.v. in 30-120 minutes.
Sponsors & Collaborators
-
Shanghai 10th People's Hospital
collaborator OTHER -
Shanghai Juncell Therapeutics
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-09-26
- Primary Completion
- 2026-09-25
- Completion
- 2027-09-25
Countries
- China
Study Locations
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