Actively Recruiting
A Clinical Study on Signal Switch Receptor Modified Tumor Infiltrating Lymphocytes Injection (GC201 TIL) in Patients With Gynecologic Tumors
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Shanghai 10th People's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of signal switch receptor modified tumor-infiltrating lymphocytes (GC201 TIL) in women with advanced gynecologic tumors. This early-phase study focuses on patients who have primary, relapsed, or metastasized gynecologic cancers and have not responded to standard treatments or have no standard options available. The modified TILs are designed to enhance immune activity by converting suppressive signals in the tumor environment into persistent T cell activation. Participants receive autologous TILs that have been gene-modified to express either TGF-b2 or PD-1 signal switch receptors. These cells are expanded in the lab and then infused intravenously in doses ranging from 2x10^8 to 1x10^10 cells. Before infusion, patients undergo a non-myeloablative lymphodepletion treatment using hydroxychloroquine (single 600 mg dose) and cyclophosphamide. The infusion lasts between 30 to 120 minutes. Throughout the study, participants will be monitored for adverse events up to 6 months and evaluated for response rates, disease control, response duration, progression-free survival, and overall survival up to 36 months. Quality of life changes will also be assessed. Participants must attend follow-up visits and meet laboratory and clinical requirements. The total participation duration spans several years to thoroughly assess treatment impact and safety.
CONDITIONS
Brief Title
A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histological diagnosis of primary, relapsed, or metastasized gynecologic tumors
- Expected life span longer than 3 months
- Karnofsky score of 60% or higher, or ECOG score between 0 and 2
- Failed standard treatment or no standard treatment available
- Tumor regions suitable for biopsy or resection, or malignant fluid where TILs can be isolated
- At least one tumor lesion that can be evaluated
- Hematology and chemistry tests within 7 days before enrollment meet specific thresholds
- No contraindications to surgery or biopsy
- Women with child-bearing potential agree to use effective contraception during and 1 year after lymphodepletion
- No cancer-targeting therapy within 28 days before TIL collection
- Able to understand and sign informed consent
- Able to follow study visit plan and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Forced expiratory volume in 1 second less than 2 liters or lung diffusion capacity less than 40%
- Severe heart conditions including NYHA Grade III or IV heart failure, low blood pressure, uncontrolled coronary artery disease, or ejection fraction under 35%
- Severe cardiac rhythm problems requiring treatment
- HIV infection or positive HIV antibody, active hepatitis B or C, syphilis or positive Treponema pallidum antibody
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Treatment with other medications, biologics, chemotherapy, or radiotherapy within one month
- Allergy to substances similar to cell therapy
- Previous immunotherapy adverse events over Grade 3
- Unresolved adverse effects from previous anti-tumor treatment above Grade 1 (excluding alopecia)
- Pregnancy or breastfeeding
- History of organ or stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single infusion with prior lymphodepletion treatment
Participants receive an infusion of autologous signal switch receptor modified tumor infiltrating lymphocytes (GC201 TIL) after non-myeloablative lymphodepletion treatment including hydroxychloroquine and cyclophosphamide.
1 treatment visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety, response, and quality of life after treatment.
Regular visits for up to 36 months
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
C
Clinical GC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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