Actively Recruiting
A Study of GC101 TIL in r/r Gastrointestinal Tumors (10hospital)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-23
50
Participants Needed
1
Research Sites
265 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 tumor infiltrating lymphocyte (TIL) therapy in patients with malignant refractory/relapsed gastrointestinal tumors. Autologous TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.
CONDITIONS
Official Title
A Study of GC101 TIL in r/r Gastrointestinal 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 gastrointestinal tumors
- Expected life span longer than 3 months
- Karnofsky score of 60% or higher, or ECOG score between 0 and 2
- Failed standard treatment regimens or no standard treatments available
- Tumor sites suitable for biopsy, resection, or malignant body fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Hematology and chemistry values within specified limits within 7 days prior to enrollment
- No absolute or relative contraindications to operation or biopsy
- Willingness to use effective contraception during study and for 1 year after lymphodepletion if of child-bearing potential
- Discontinuation of tumor-targeting therapies at least 28 days before TIL collection
- Ability to understand and sign informed consent
- Ability to comply with follow-up visits and study requirements
You will not qualify if you...
- Need for glucocorticoid treatment exceeding prednisone 15mg daily or autoimmune diseases requiring immunomodulatory therapy
- Forced expiratory volume in 1 second (FEV1) less than 2 liters or lung diffusing capacity (DLCO) less than 40%
- Significant cardiovascular diseases including NYHA Class III/IV heart failure, low blood pressure, symptomatic coronary artery disease, or ejection fraction below 35%
- Severe cardiac rhythm or conduction abnormalities requiring clinical intervention
- HIV infection or positive anti-HIV antibody, active HBV or HCV infection, syphilis infection or positive Treponema pallidum antibody
- Severe physical or mental illness
- Active systemic infections requiring treatment or positive blood cultures
- Treatment with other medicines, biologics, chemotherapy, or radiotherapy within 1 month or ongoing
- Allergy history to chemical or biologic substances similar to cell therapy
- Previous immunotherapy with immune-related adverse events above grade 3
- Unresolved adverse events from prior anti-tumor treatments above grade 1 (except alopecia)
- Pregnancy or lactation
- History of organ transplantation, stem cell transplantation, or renal replacement therapy
- Any other severe systemic diseases or conditions deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, China
Actively Recruiting
Research Team
G
GC Clinical
CONTACT
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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