Actively Recruiting
A Study of GC101 TIL in Advanced Hepatobiliary-Pancreatic Cancers (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 hepatobiliary-pancreatic cancers. 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 Hepatobiliary-Pancreatic Cancers (10hospital)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed primary, relapsed, or metastatic hepatobiliary or pancreatic cancer
- Expected life expectancy longer than 3 months
- Karnofsky score 60% or higher, or ECOG score between 0 and 2
- Failed standard treatments or no standard treatments available
- Tumor areas suitable for biopsy or resection, or malignant fluid available for TIL isolation
- At least one tumor lesion that can be evaluated
- Blood tests within 7 days before enrollment meeting specific counts and levels (white blood cells, neutrophils, lymphocytes, platelets, hemoglobin, coagulation times, kidney and liver function)
- No absolute or relative contraindications for surgery or biopsy
- Willing to use highly effective contraception during the study and for 1 year after lymphodepletion if of child-bearing potential
- No cancer-targeting therapies (radiotherapy, chemotherapy, biologics) within 28 days before TIL collection
- Able to understand and sign informed consent
- Able to follow the study visit schedule and other requirements
You will not qualify if you...
- Need for glucocorticoid treatment exceeding daily prednisone 15 mg or equivalent, or autoimmune diseases requiring immunomodulation
- Forced expiratory volume in 1 second less than 2 liters or lung diffusion capacity less than 40%
- Severe heart problems including NYHA Class III or IV heart failure, low blood pressure, uncontrolled coronary disease, or ejection fraction below 35%
- Severe heart rhythm or conduction problems requiring intervention
- HIV infection or positive antibodies, active hepatitis B or C infection, syphilis infection
- Severe physical or mental illness
- Active systemic infection requiring treatment or positive blood cultures
- Treatment with other medicines, biologics, chemotherapy, or radiotherapy within the past month or ongoing
- History of allergy to substances similar to cell therapy
- Prior immunotherapy causing severe immune-related adverse effects above grade 3
- Previous cancer treatment adverse effects not resolved to grade 1 or lower (except minor issues like hair loss)
- Pregnant or breastfeeding females
- History of organ transplantation, stem cell transplantation, or kidney replacement therapy
- Other severe systemic diseases or reasons considered 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
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China, 200000
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
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