A Phase 1/2 interventional study of Infusion of iNKT cells and CD8+T cells in Non-small Cell Lung Cancer, Small Cell Lung Cancer and Pancreas Cancer, sponsored by Shanghai Public Health Clinical Center. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-07-02.
Sponsored by Shanghai Public Health Clinical Center · Phase 1/2, Interventional, and Treatment
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.
Treatment of patients with advance solid tumor is great unsolved challenge to the physicians. Efficacy of conventional treatment, such as surgery, radiotherapy and chemotherapy is limited. AS novel therapy, immunotherapy shows great prospects.
Human iNKT cells can directly lysis tumor cells by a perforin-dependent mechanism,and intracellular granzyme B expression may also potentiate cell killing. Tumor cells expressing CD1d may be especially susceptible to direct NKT cell lysis. iNKT cells play important role in immune regulation by secreting various cytokines. PD-1+CD8+T cells are most likely tumor-specific in patient with advanced tumor. Expansion method of iNKT cells and PD-1+CD8+T cells in vitro is developed as published in our patent. Infusions of iNKT cells and CD8+T cell have been proved safe in mice.
In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells and CD8+T cells are assessed.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 40 is below the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Shanghai Public Health Clinical Center is the lead sponsor of 37 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The eligible patient receive the experimental infusion of iNKT cells and CD8+T cells .
Biological: Infusion 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.
Incidence of adverse events related to the infusion of cells
The incidence of adverse events following infusion of iNKT cells and CD8+T cells
Time frame: 28 days post-infusion
Objective Response Rate (ORR)
Change of target focus confirmed by CT or MRI
Time frame: up to 4 months post-infection
Hematologic analysis
Hematologic analysis is used to assess the impact of infusion to the cells in blood, including erythrocytes, leukocytes, platelets, T lymphocytes , B lymphocytes, Natural killer cell, NKT, CD4/CD8, and Treg lymphocytes.
Time frame: Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment
Liver biochemical examination
Liver Biochemical examination is a serological analysis about the metabolites related to the function of liver , such as immunoglobulins, Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin (PA), total bilirubin (TB), and direct bilirubin (DB).
Time frame: Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment
Kidney biochemical examination
Kidney Biochemical examination is a serological analysis about the metabolites related to the function of liver, such as Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr).
Time frame: Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment
Tumor Marker
Tumor Marker
Time frame: Base line, the day before the first infusion in each course of treatment and up to 12 weeks after the treatment
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Time frame: Approximately 1 years after the treatment
Plan to share: No
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Carcinoma, Non-Small-Cell Lung→
Shanghai Public Health Clinical Center