RecruitingPhase 1Phase 2NCT03093688

Clinical Safty and Efficacy Study of Infusion of iNKT Cells and CD8+T Cells in Patients With Advanced Solid Tumor

Phace I and II Study of Immunotherapy Strategy Used iNKT Cells and CD8+T Cells in Patients With Advanced Tumor


Sponsor

Shanghai Public Health Clinical Center

Enrollment

40 participants

Start Date

Mar 1, 2017

Study Type

INTERVENTIONAL

Conditions

Summary

Invariant Natural killer T (iNKT) cells are a unique subset of lymphocytes that express homogeneous TCR recognizing KRN7000 which was up-regulated by many kinds of cancer cells. PD-1+CD8+T cells of patients with advanced tumor are most likely tumor-specified. Our hypothesis is that immunotherapy strategy of infusion of iNKT cells and PD-1+CD8+T cells may decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of patients with advanced solid tumor by infusing of iNKT cells and PD-1+CD8+T cells.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This trial tests the safety and effectiveness of infusing two types of immune cells — iNKT cells and CD8+ T cells — in patients with advanced solid tumors (such as lung, stomach, pancreatic, liver, or colorectal cancer) to see if these immune cells can attack and shrink the cancer. **You may be eligible if...** - You have an advanced cancer confirmed by biopsy — specifically lung, gastric (stomach), pancreatic, liver (hepatocellular carcinoma), or colorectal cancer - Your blood counts and organ function (kidneys, liver) are within acceptable ranges - You are in good functional health (Karnofsky score 80% or above) and your oxygen levels are adequate - You do not have a genetic disease - You are willing to use contraception and have a negative pregnancy test (if applicable) - You are willing to participate in long-term follow-up for up to 1 year **You may NOT be eligible if...** - You have a serious heart condition, recent heart attack, kidney failure, or respiratory failure - You have lymphoma or leukemia (blood cancers) - You have a serious active infection - You are HIV positive, or have active hepatitis B or C - You are currently receiving chemotherapy or another experimental treatment - You have an immune deficiency or autoimmune disease - You are pregnant or breastfeeding 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

BIOLOGICALInfusion of iNKT cells and CD8+T cells

The eligible patients receive twice infusions of iNKT cells(1E8\~1E10) and CD8+T cells(1E7\~1E9) in one course of treatment.


Locations(1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

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NCT03093688


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