Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor
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|ClinicalTrials.gov Identifier: NCT03551795|
Recruitment Status : Recruiting
First Posted : June 11, 2018
Last Update Posted : June 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumor||Biological: Infusion of iNKT cells||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Research on Comprehensive Treatment of Tuberculosis With Malignant Solid Tumor|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
The eligible patient receive the experimental infusion of iNKT cells.
Biological: Infusion of iNKT cells
The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment.
- Objective Response Rate (ORR) [ Time Frame: up to 4 months post-infection ]Change of target focus confirmed by CT or MRI
- Incidence of adverse events related to the infusion of cells [ Time Frame: 28 days post-infusion ]The incidence of adverse events following infusion of iNKT cells
- Progression-Free Survival (PFS) [ Time Frame: Approximately 1 years after the treatment ]Progression-Free Survival (PFS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03551795
|Contact: Yan X Zhang, Ph.D||0086-021-37990333 ext firstname.lastname@example.org|
|Contact: Qing J Xu, Ph.D|
|Shanghai Public Health Clinical Center, Fudan University||Recruiting|
|Shanghai, China, 201508|
|Contact: Yan X Zhang, Ph.D|
|Study Chair:||Qing J Xu, Ph.D||Shanghai Public Health Clinical Center, Fudan University, 2901 Caolang Road, Jin Shan, Shanghai 201508, P.R. China|