Actively Recruiting
A Study of GC201 TIL in Advanced Gynecologic Tumors (10hospital)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
312 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
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
Official 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
- Histologically confirmed primary, relapsed, or metastatic gynecologic tumors
- Expected life span longer than 3 months
- Karnofsky score 60% or higher, or ECOG score 0 to 2
- Failed standard treatments or no standard treatments available
- Tumor regions or malignant fluid suitable for biopsy or TIL isolation
- At least one tumor lesion that can be evaluated
- Blood tests within 7 days before enrollment meeting specific counts and levels for white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, coagulation times, kidney and liver function
- No contraindications for operation or biopsy
- Women of child-bearing potential must agree to use effective contraception during the study and for one year after lymphodepletion
- No cancer-targeting therapies (radiotherapy, chemotherapy, biologics) within 28 days before TIL collection
- Able to understand and sign informed consent
- Willing and able to follow study visit plans and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone >15 mg daily or immunomodulatory treatment for autoimmune diseases
- Lung function with FEV1 less than 2 liters or DLCO less than 40%
- Significant heart problems including severe heart failure, low blood pressure, coronary artery disease, or serious heart rhythm issues
- Infection with HIV, active hepatitis B or C, syphilis, or positive antibodies for these infections
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Receiving other treatments or biologics, chemotherapy, or radiotherapy within last month or currently
- History of allergy to substances similar to cell therapy
- Prior immunotherapy with severe immune-related adverse events (level greater than 3)
- Previous cancer treatment side effects not resolved to mild levels
- Pregnancy or breastfeeding
- History of organ or stem cell transplant or kidney replacement therapy
- Other severe systemic diseases or conditions considered inappropriate for the study by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
C
Clinical GC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here