Trials / Recruiting
RecruitingNCT05098171
A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)
A Clinical Study on Signal Switch Receptor Modified Tumor Infiltrating Lymphocytes Injection (GC201 TIL) in Patients With Gynecologic Tumors
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Shanghai Juncell Therapeutics · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-09-26
- Primary completion
- 2026-09-25
- Completion
- 2027-09-25
- First posted
- 2021-10-28
- Last updated
- 2025-12-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05098171. Inclusion in this directory is not an endorsement.