Actively Recruiting
A Phase I Study to Evaluate the Safety and Efficacy of Engineering Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Malignant Solid Tumors
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-11
18
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of engineered Tumor Infiltrating Lymphocytes (TIL) called GC203 TIL in patients with advanced malignant solid tumors. This Phase I clinical trial focuses on patients who have metastatic solid tumors such as gynecologic, breast, gastrointestinal, or lung cancers and have not responded to standard therapies including chemotherapy, radiotherapy, targeted treatments, immunotherapy, or surgery. The study involves removing a tumor sample from each participant to grow and engineer TILs outside the body. After preparing the patient with lymphodepletion, they receive an infusion of GC203 TIL followed by a low-dose PD-1 antibody. This intervention is the main treatment being assessed for safety and potential benefit. The trial includes one treatment arm administering this engineered TIL therapy. Participants will be closely monitored for up to one year to assess safety, including maximum tolerated dose and adverse events, and to evaluate tumor response and disease progression at regular intervals every 6 weeks. Quality of life will also be assessed during this period. The study requires patients to meet specific health and laboratory criteria and have an expected life expectancy of at least 3 months. The total participation period can last up to 12 months with ongoing evaluations.
CONDITIONS
Brief Title
A Study of GC203 TIL in Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to sign informed consent and complete all study procedures
- Age 18 to 75 years at time of consent
- Diagnosed with advanced metastatic solid tumors including gynecologic, breast, gastrointestinal, or lung cancer with failure of standard therapies
- Feasible tumor tissue available for resection or biopsy larger than 400 mm3, not recently treated locally or progressed after local treatment
- At least one measurable target lesion as defined by RECIST1.1
- ECOG performance status 0 or 1
- Estimated life expectancy of at least 3 months
- Adequate blood counts, coagulation, liver and kidney function as specified
- Women of childbearing potential must have negative pregnancy test and all sexually active participants agree to effective birth control
- No contraindications for surgery or biopsy
- Good compliance and ability to follow study protocol
You will not qualify if you...
- Participation in other drug or biologic clinical trials within 4 weeks before enrollment
- History of allogeneic T cell therapy or gene-engineered autologous cell therapy within 1 year
- Systemic antitumor therapy within 4 weeks prior to study
- Another primary malignancy within previous 5 years
- Live or attenuated vaccination within 28 days prior to treatment
- History of hypersensitivity to study drug components
- Pregnant or breastfeeding women
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 28 days
Participants undergo tumor tissue resection or biopsy to generate engineered tumor infiltrating lymphocytes (GC203 TIL). After lymphodepletion, they receive an infusion of GC203 TIL followed by low-dose PD-1 antibody.
1 treatment visit and frequent monitoring visits up to Day 28
Duration - Up to 12 months
Participants are monitored for adverse events and treatment response with assessments every 6 weeks for up to 12 months.
Visits every 6 weeks for 12 months
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Actively Recruiting
Research Team
H
Huajun Jin, PhD
X
Xiaohua Wu, Phd
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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