Actively Recruiting
A Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors
Led by Shanghai Juncell Therapeutics · Updated on 2025-12-16
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Shanghai Juncell Therapeutics
Lead Sponsor
E
Eastern Hepatobiliary Surgery Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. This early phase 1 study involves expanding both autologous and gene-edited TILs from tumor tissue samples. The purpose is to investigate how these TIL therapies perform following a preparative lymphodepletion treatment that includes hydroxychloroquine and cyclophosphamide. Participants receive an intravenous infusion of either GC203 gene-edited TILs or autologous TILs after non-myeloablative lymphodepletion with a single dose of hydroxychloroquine (600 mg) and cyclophosphamide. The assignment to either GC203 or autologous TILs depends on the volume of the TIL sample obtained. The study has two experimental arms and is randomized without masking. During the study, participants will be monitored for adverse events over 6 months and evaluated for tumor response and disease control for up to 36 months. Assessments include measuring the objective response rate, duration of response, and progression-free survival. Patients must have at least one evaluable tumor lesion and are evaluated regularly to track safety and treatment effects under medical supervision.
CONDITIONS
Brief Title
A Study of TIL in Advanced Solid Tumors (DFGD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have undergone tumor resection for TIL production and successfully produced TILs
- Age between 18 and 75 years
- Histologically confirmed diagnosis of solid tumors
- Expected life span longer than 3 months
- ECOG performance status of 0 or 1
- Have failed standard treatment regimens and are willing to receive TIL therapy
- Have at least one tumor lesion that can be evaluated
You will not qualify if you...
- Have other malignant tumors except those cured, inactive for 5 years or more, or non-melanoma skin cancers adequately treated with no recurrence
- Require glucocorticoid treatment with prednisone over 10 mg daily or have autoimmune diseases needing immunomodulatory treatment
- Have oxygen saturation below 95% at rest
- Are infected with HIV, active hepatitis B or C, syphilis, or Treponema pallidum
- Have significant cardiovascular abnormalities
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 36 months
Participants receive gene-edited or autologous tumor infiltrating lymphocytes (TILs) after non-myeloablative lymphodepletion treatment with hydroxychloroquine and cyclophosphamide.
1 infusion visit followed by multiple follow-up visits
Trial Site Locations
Total: 1 location
1
Third Affiliated Hospital of Naval Medical University
Shanghai, China
Actively Recruiting
Research Team
G
GC Clinical
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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