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Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells (MDR-TB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575299
Recruitment Status : Unknown
Verified June 2018 by Zhinan Yin, Ph.D., Jinan University Guangzhou.
Recruitment status was:  Recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Shenzhen Third People's Hospital
Information provided by (Responsible Party):
Zhinan Yin, Ph.D., Jinan University Guangzhou

Study Description
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Brief Summary:
Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB，and then the safety and efficacy of γδT cells will be evaluated.

Condition or disease Intervention/treatment Phase
Multi-drug Resistant Tuberculosis Biological: The adoptive treatment of allogeneic γδT cells Other: Control Drug: Conventional treatment Phase 1

Detailed Description:
All patients with multi-drug resistant pulmonary tuberculosis will be assigned into 2 groups(study group and control group)，both groups will receive conventional treatment. Allogeneic γδT cell will be administrated intravenously to patients in the study group (but not the control group) every two weeks for 6 months
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
 Biological: The adoptive treatment of allogeneic γδT cells
Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.

Drug: Conventional treatment
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
Placebo Comparator: Control Group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
 Other: Control
No allogeneic γδT cells will be administered to patients with MDR-TB.

Drug: Conventional treatment
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.


Outcome Measures
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Primary Outcome Measures :
  1. sputum smear [ Time Frame: 6 months ]
    The sputum specimens will be collected biweekly in the first 2 months and bimonthly thereafter for sputum smear to study the time (months) of the sputum conversion. The sputum conversation rate will be analyzed at the end of study.


Secondary Outcome Measures :
  1. Sputum tubercle bacillus culture [ Time Frame: 6 months ]
    The sputum specimens will be collected for culture to detect the TB biweekly in the first 2 months and bimonthly thereafter to study the time (months) of the sputum conversion. The sputum conversation rate will be analyzed at the end of study.

  2. Fecal microbiome analysis [ Time Frame: 6 months ]
    The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.

  3. Assessment of immune function [ Time Frame: 6 months ]
    Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 18-50 years old, male or female;
  2. Informed consent;
  3. Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.

Exclusion Criteria:

  1. AIDS, hepatitis B and other viruses, bacterial infections;
  2. Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
  3. Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
  4. Those who do not agree to be included.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03575299


Contacts
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Contact: Zhinan Yin, Ph.D. (+86)18818801179 zhinan.yin@yale.edu
Contact: Yangzhe Wu, Ph.D. (+86)18826469480 190374157@qq.com

Locations
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China, Guangdong
Shenzhen Third People's Hospital Recruiting
Shenzhen, Guangdong, China, 518000
Contact: Guoliang Zhang, Ph.D    (+86)13823317076    szdsyy@yahoo.com.cn   
Contact: Guofang Deng, Master    (+86)13530027001    jxxk1035@yeah.net   
Sponsors and Collaborators
Zhinan Yin, Ph.D.
Shenzhen Third People's Hospital
Investigators
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Principal Investigator: Guofang Deng, Master Partner
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhinan Yin, Ph.D., Dean of Biomedical Translational Research Institute，jinan University, Jinan University Guangzhou
ClinicalTrials.gov Identifier: NCT03575299    
Other Study ID Numbers: GDT-MDR-TB-069
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhinan Yin, Ph.D., Jinan University Guangzhou:
MDR-TB
Allogeneic γδT cells
adoptive treatment
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
 Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections