Actively Recruiting
A Study of GC101 TIL in Advanced Solid Tumors (TR)
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
S
Shanghai Tong Ren 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 malignant solid 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 Advanced Solid Tumors (TR)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Histologically confirmed primary, relapsed, or metastasized malignant tumors
- Expected life-span more than 3 months
- Karnofsky score 60% or higher or ECOG score 0 to 2
- Failed standard treatments or no standard treatments available
- Tumor regions available for biopsy or resection, or malignant body fluid for TIL isolation
- At least one evaluable tumor lesion
- Hematology and chemistry tests within 7 days before enrollment meeting specified blood counts and liver/kidney function
- No contraindications to operation or biopsy
- Willingness to use effective contraception during study and for 1 year after lymphodepletion
- Malignant tumor-targeting therapies stopped at least 28 days before TIL collection
- Ability to understand and sign informed consent
- Willingness to follow study visit plans and requirements
You will not qualify if you...
- Need for glucocorticoid treatment with prednisone over 15 mg daily or immunomodulatory treatment for autoimmune diseases
- Lung function with FEV1 less than 2L or DLCO less than 40%
- Significant cardiovascular problems including NYHA Grade III/IV heart failure, low blood pressure, uncontrolled coronary artery disease, or ejection fraction below 35%
- Severe cardiac rhythm or conduction disorders requiring intervention
- HIV infection or positive anti-HIV antibody, active hepatitis B or C infection, syphilis infection
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Receiving other medications, biologics, chemotherapy, or radiotherapy within one month or currently
- Allergy history to chemical or biological substances similar to cell therapy
- Previous immunotherapy adverse events above level 3
- Previous anti-tumor treatment adverse events not resolved to grade 1 or below
- Pregnancy or breastfeeding
- History of organ or stem cell transplantation, or renal replacement therapy
- Other severe systemic diseases or reasons deemed inappropriate by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongren Hospital Shanghai Jiao Tong University School Of Medicine.
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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