Actively Recruiting
An Open, Single-Arm Phase Ib Study Evaluating Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL) in Patients With Non-Small Cell Lung Cancer
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of autologous tumor infiltrating lymphocytes (GC101 TIL) in patients with advanced non-small cell lung cancer (NSCLC) who have specific genetic markers and have not responded to prior therapies. This Phase Ib clinical trial aims to assess the safety and effectiveness of this biological treatment in a group of about 20 participants over 36 months. Each participant will have a tumor sample taken and cultured to produce the GC101 TIL cells. After a preparatory treatment to reduce lymphocytes, patients will receive an infusion of these cells followed by a low dose of a PD-1 antibody. This is a single-arm study where all enrolled participants receive the experimental treatment. Participants will be closely monitored through various assessments including safety checks for adverse events up to 28 days and over a maximum of 360 days, as well as evaluation of tumor response and disease progression for up to 36 months. The study will also track overall survival and treatment effects through clinical visits and laboratory tests. The total involvement is expected to last around 36 months.
CONDITIONS
Brief Title
A Phase Ib Study of GC101 in NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study visits and procedures
- Aged 18 to 70 years, any gender
- Diagnosed with unresectable advanced, recurrent, or metastatic non-small cell lung cancer positive for driver genes and failed targeted and platinum-based chemotherapy
- Tumor infiltrating lymphocytes can be isolated from a surgically resectable tumor region with tissue volume >150 mm3 and no recent local treatment or progression after local treatment
- At least one measurable lesion remains after tumor tissue sampling
- ECOG performance status of 0 or 1
- Expected survival time of more than 3 months
- Adequate blood counts and organ function based on recent lab tests
- Agreement to use effective contraception if applicable
- No contraindications to surgery
- Stopped prior melanoma treatments at least 28 days before infusion (shorter if small molecular targeted drugs used)
- Good compliance with study requirements
You will not qualify if you...
- More than 5 lines of systemic therapy in the past 3 years before screening
- Participation in another drug or biologic clinical trial or similar cellular therapy within 28 days before infusion
- Having two or more malignant tumors except certain treated or inactive tumors
- Recent live attenuated vaccination or scheduled to receive during study
- Not recovered from prior treatment-related adverse reactions above grade 1
- Known allergies to components used in treatment
- Uncontrolled or unstable cardiovascular diseases
- High risk or recent gastrointestinal bleeding or portal hypertension
- Uncontrolled metabolic or systemic diseases increasing medical risk
- Severe liver disease or failure
- Serious organic or psychiatric disease
- Active systemic infection requiring treatment
- Positive tests for HIV, syphilis, or active hepatitis viruses
- Active autoimmune diseases requiring immunosuppressive treatment
- Immune-related adverse effects grade 3 or higher from prior immunotherapy
- History of organ transplant or certain cell therapies
- Lung diseases like pulmonary fibrosis, interstitial lung disease, or severe obstructive/restrictive lung disease
- Uncontrollable fluid accumulations
- Symptomatic brain metastases or unstable treated brain metastases
- Pregnant or breastfeeding women
- Any other conditions deemed unsuitable by the investigator
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 - Up to Day 28
Participants receive autologous tumor infiltrating lymphocytes (GC101 TIL) infusion following lymphodepletion and low-dose PD-1 antibody.
1 treatment visit and several follow-up visits up to Day 28
Duration - Up to 36 months
Participants are monitored for safety and treatment response up to 36 months after treatment.
Periodic visits for assessments up to 36 months
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
S
Shun Lu, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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