Actively Recruiting
A Study of GC101 TIL in Advanced Melanoma (10hospital)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
260 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 advanced melanoma. 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 Advanced Melanoma (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histological diagnosis of primary, relapsed, or metastatic melanoma
- Expected life expectancy of more than 3 months
- Karnofsky score of 60% or higher, or ECOG performance status 0 to 2
- Failed standard treatment regimens or no standard treatments available
- Presence of tumor areas suitable for biopsy, resection, or malignant fluid for TIL isolation
- At least one tumor lesion that can be evaluated
- Hematology and chemistry tests within 7 days before enrollment meeting specified thresholds for white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, coagulation times, kidney and liver function
- No absolute or relative contraindications to surgery or biopsy
- Willingness to use approved effective contraception if of childbearing potential, continuing for 1 year after lymphodepletion
- Cessation of other 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 with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Forced expiratory volume in one second (FEV1) less than 2 liters or lung diffusing capacity (DLCO) below 40%
- Severe cardiovascular diseases including NYHA class III or IV heart failure, uncontrolled low blood pressure, significant coronary artery disease, ejection fraction below 35%, or serious heart rhythm/conduction problems
- Infection with HIV, active hepatitis B or C, syphilis, or positive antibodies for these infections
- Severe physical or mental illnesses
- Active systemic infection requiring treatment or positive blood cultures
- Treatment with other medications, biologics, chemotherapy, or radiotherapy within the past month or ongoing
- History of allergy to chemical or biological substances similar to cell therapy
- Previous immunotherapy-related adverse events at grade 4 or higher
- Previous anti-tumor treatment adverse events not recovered to grade 1 or lower (except minor non-safety concerns)
- Pregnancy or breastfeeding
- History of organ or stem cell transplantation or renal replacement therapy
- Other severe systemic diseases or conditions deemed inappropriate for study participation by investigators
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, China
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