Actively Recruiting
A Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor Infiltrating Lymphocytes Injection in Patients With Advanced Melanoma
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
50
Participants Needed
1
Research Sites
N/A
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 tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma, a serious form of skin cancer. This early phase study focuses on giving patients TILs grown from their own tumor samples after a mild lymphodepletion treatment using hydroxychloroquine and cyclophosphamide. The goal is to better understand how this treatment affects the disease and patient outcomes. Participants receive an infusion of 1 billion to 50 billion autologous TILs through an intravenous line over 30 to 120 minutes. Before the infusion, patients undergo a non-myeloablative lymphodepletion regimen that includes a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The treatment is given after tumor cells are collected and expanded in the lab. There are no placebo groups or masking in this study. During the study, patients will be closely monitored for adverse events for up to six months and followed for treatment responses, disease control, progression-free survival, and overall survival for up to three years. Quality of life changes will also be tracked. Participants will have regular lab tests and clinical assessments to evaluate safety and treatment effects. The total participation duration varies depending on individual follow-up.
CONDITIONS
Brief 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
- Diagnosed with primary, relapsed, or metastatic melanoma
- Expected life span of more than 3 months
- Karnofsky score of 60% or higher, or ECOG score between 0 and 2
- Have failed standard treatments or no standard treatments are available
- Have tumor areas suitable for biopsy or resection, or malignant fluid for TIL isolation
- Have at least one tumor lesion that can be evaluated
- Meet specific blood and chemistry lab values within 7 days before enrollment
- No contraindications for surgery or biopsy
- Willing to use highly effective contraception during the study and for one year after lymphodepletion
- Have stopped any tumor-targeted therapy, including radiotherapy, chemotherapy, or biologics, at least 28 days before TIL collection
- Able to understand and sign informed consent
- Able to follow study visit schedules and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15mg daily or immunomodulatory treatment for autoimmune diseases
- Lung function with forced expiratory volume in one second less than 2L or lung diffusion capacity less than 40%
- Significant heart problems such as severe heart failure, low blood pressure, unstable coronary artery disease, or low ejection fraction under 35%
- Severe heart rhythm or conduction issues requiring intervention
- Infection with HIV, active hepatitis B or C, syphilis, or positive related antibodies
- Severe physical or mental illness
- Active infection requiring treatment or positive blood cultures
- Use of other medicines, biologic therapy, chemotherapy, or radiotherapy within one month before or during the study
- Allergy to compounds similar to cell therapy
- Previous immunotherapy with severe immune-related adverse effects above level 3
- Previous anti-tumor treatment side effects not resolved to mild or better
- Pregnancy or breastfeeding
- History of organ transplant, stem cell transplant, or kidney replacement therapy
- Other severe systemic diseases or reasons deemed inappropriate by investigators
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 treatment session with lymphodepletion and TIL infusion
Participants receive lymphodepletion treatment with hydroxychloroquine and cyclophosphamide followed by infusion of autologous tumor infiltrating lymphocytes (TILs).
1 treatment visit (in-person)
Duration - Up to 36 months
Participants are monitored for safety and efficacy outcomes after treatment.
Regular visits over 36 months for assessments and monitoring
Trial Site Locations
Total: 1 location
1
Shanghai Tenth People's Hospital
Shanghai, China
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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