Actively Recruiting
A Study of GC101 TIL in Advanced Melanoma
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-23
98
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
98 participants will be randomly assigned 1:1 to the experimental group and the control group for the Phase II clinical trial，this trail is expected to be finished in 24 months
CONDITIONS
Official Title
A Study of GC101 TIL in Advanced Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Aged 18 to 75 years, any gender
- Diagnosed with unresectable advanced, recurrent, or metastatic melanoma (excluding uveal melanoma)
- Failed or resistant to PD-1 antibody treatment
- Failed at least two prior systemic therapies; if BRAF mutation present, also failed BRAF/MEK inhibitors; if NRAS mutation present, also failed Tunlametinib
- Tumor tissue available for TIL isolation, volume over 150 mm3, untreated or progressed after local treatment
- At least one measurable lesion after tumor sampling and resection
- ECOG performance status 0-1
- Expected survival longer than 3 months
- Adequate blood and organ function
- Good compliance and ability to adhere to study requirements
You will not qualify if you...
- Received any investigational drug within 28 days before screening
- More than one malignant tumor unless inactive for 5+ years with minimal recurrence risk or certain treated skin cancers without recurrence
- Received live attenuated vaccine after consent or planned during study
- Not recovered from prior adverse reactions above grade 1, except minor toxicities judged safe
- Allergy to streptomycin, ciprofloxacin, micafungin, or formulation components
- Uncontrolled hypertension or unstable cardiovascular disease within 6 months prior
- High risk or recent esophageal/gastric varices requiring intervention
- Uncontrolled metabolic disorders or serious non-malignant diseases increasing medical risk
- Severe liver disease or failure
- Serious organic or mental disorders
- Active systemic infections including tuberculosis
- Infectious diseases like hepatitis B/C, syphilis, AIDS
- Active autoimmune diseases requiring systemic treatment recently, except certain stable conditions
- Severe immune-related adverse reactions from prior immunotherapy
- History of organ transplantation or renal replacement therapy
- Lung diseases including fibrosis or interstitial lung disease
- Leptomeningeal metastasis
- Active brain metastases symptoms; stable treated brain metastases may be eligible
- Pregnant or breastfeeding women
- Prior TIL, allogeneic T cell, or NK cell therapy within 6 months
- Any condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Cancer Hospital
Beijing, China
Actively Recruiting
Research Team
J
Jun Guo, Prof. Dr. Med
CONTACT
W
Wei Shi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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