Actively Recruiting
A Phase Ib Study of GC101 in NSCLC
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
20
Participants Needed
1
Research Sites
141 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.
CONDITIONS
Official 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 procedures
- Aged 18 to 70 years, any gender
- Diagnosed with unresectable advanced, recurrent, or metastatic non-small cell lung cancer positive for driver genes
- Failed prior targeted and platinum-containing dual chemotherapy
- Tumor infiltrating lymphocytes can be isolated from a surgically resectable tumor region with tissue volume >150 mm3
- At least one measurable lesion remains after tumor tissue collection
- ECOG performance status of 0 or 1
- Expected survival time longer than 3 months
- Adequate hematology and organ function confirmed by lab tests within 7 days before tumor tissue collection
- Premenopausal women and men agree to use effective contraception from study start to one year after cell infusion
- No contraindications for surgery
- All prior melanoma treatments stopped 28 days before infusion (exceptions apply for small molecular targeted drugs)
- Good compliance and able to adhere to study visit schedule
You will not qualify if you...
- More than 5 lines of systemic therapy used in past 3 years
- Participated in another drug or biologic clinical trial or received comparable cellular therapy within 28 days
- Multiple malignant tumors except certain inactive or treated cancers
- Received live attenuated vaccine after consent or planned during study
- Not recovered from prior treatment-related adverse events above grade 1 (except minor toxicities)
- Known allergies to streptomycin, ciprofloxacin, micafungin, or components of infused product
- Uncontrolled co-morbidities including severe cardiovascular diseases
- High risk or history of esophageal or gastric varices without recent endoscopic evaluation
- Uncontrolled metabolic or systemic diseases increasing medical risk
- Severe liver disease or failure
- Serious organic or psychiatric diseases
- Active systemic infections requiring treatment
- HIV positive, active hepatitis A, B, or C infection
- Active autoimmune diseases requiring systemic steroids or immunosuppressants
- Prior severe immune-related adverse effects from immunotherapy
- History of organ transplant or stem cell therapy
- Severe lung diseases or impaired lung function (FEV1 <70%)
- Uncontrollable fluid effusions
- Symptomatic central nervous system metastases
- Pregnant or breastfeeding women
- Other investigator-determined unsuitable conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, China
Actively Recruiting
Research Team
S
Shun Lu, M.D.
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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