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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.The hypothesis of the investigators is that immunotherapy strategy of infusion of iNKT cells may resist inflection and decrease the tumor burden and improve overall survival. The purpose of this study is to assess the safety and efficacy of treatment of tuberculosis with malignant solid tumor by infusing of iNKT cells.
Treatment of tuberculosis with malignant 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. Expansion method of iNKT cells in vitro is developed as published in the patent of the investigators. Infusion of iNKT cells has been proved safe in mice.
In this clinical trial, the safety and efficacy of the immunotherapy of infusion of iNKT cells are assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment | Experimental | The eligible patient receive the experimental infusion of iNKT cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of iNKT cells | Biological | The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Change of target focus confirmed by CT or MRI | up to 4 months post-infection |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events related to the infusion of cells | The incidence of adverse events following infusion of iNKT cells | 28 days post-infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) | Approximately 1 years after the treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qing J Xu, Ph.D | Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jin Shan, Shanghai 201508, P.R. China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center, Fudan University | Shanghai | 201508 | China |
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