RecruitingPhase 1NCT06084299

Immunotherapy Using Tumor Infiltrating Lymphocytes for Patients With Advanced Liver Cancer


Sponsor

Zhiyong Huang

Enrollment

16 participants

Start Date

May 27, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

Single-arm, open-label, interventional study evaluating adoptive cell therapy (ACT) with autologous tumor-infiltrating lymphocytes (TIL) infusion followed by IL-2 after a non-myeloablative(NMA) lymphodepletion preparative regimen for the treatment of patients with advanced liver cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of personalized immune cell therapy called tumor-infiltrating lymphocyte (TIL) therapy in patients with advanced liver cancer. In TIL therapy, immune cells extracted from the patient's own tumor are grown in large numbers and infused back to help fight the cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have confirmed advanced liver cancer that has progressed after at least two prior standard treatment regimens - You have more than 3 cancer lesions with at least one accessible for tissue collection - Your liver function is adequate (Child-Pugh grade A) - Your blood counts and organ function meet required minimums - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your cancer has spread to the brain - You have had an organ transplant - You have had major liver surgery within 4 weeks or recent serious cardiac events (heart attack, stroke, blood clots) within 12 months - You have active HIV, untreated hepatitis, or significant autoimmune disease - You are pregnant or breastfeeding - You have recently joined another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAutologous Tumor Infiltrating Lymphocytes

Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation, and extensive expansion.


Locations(1)

Tongji Hospital

Wuhan, China

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NCT06084299


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