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

Primary Purpose

Multi-drug Resistant Tuberculosis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
The adoptive treatment of allogeneic γδT cells
Control
Conventional treatment
Sponsored by
Zhinan Yin, Ph.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multi-drug Resistant Tuberculosis focused on measuring MDR-TB, Allogeneic γδT cells, adoptive treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shenzhen Third People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Study group

Control Group

Arm Description

Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.

Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.

Outcomes

Primary Outcome Measures

sputum smear
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

Sputum tubercle bacillus culture
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.
Fecal microbiome analysis
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
Assessment of immune function
Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .

Full Information

First Posted
June 19, 2018
Last Updated
June 29, 2018
Sponsor
Zhinan Yin, Ph.D.
Collaborators
Shenzhen Third People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03575299
Brief Title
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
Acronym
MDR-TB
Official Title
Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhinan Yin, Ph.D.
Collaborators
Shenzhen Third People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi-drug Resistant Tuberculosis
Keywords
MDR-TB, Allogeneic γδT cells, adoptive treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
Intervention Type
Biological
Intervention Name(s)
The adoptive treatment of allogeneic γδT cells
Intervention Description
Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
No allogeneic γδT cells will be administered to patients with MDR-TB.
Intervention Type
Drug
Intervention Name(s)
Conventional treatment
Intervention Description
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
Primary Outcome Measure Information:
Title
sputum smear
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Sputum tubercle bacillus culture
Description
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.
Time Frame
6 months
Title
Fecal microbiome analysis
Description
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
Time Frame
6 months
Title
Assessment of immune function
Description
Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-50 years old, male or female; Informed consent; Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture. Exclusion Criteria: AIDS, hepatitis B and other viruses, bacterial infections; Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases; Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy; Those who do not agree to be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhinan Yin, Ph.D.
Phone
(+86)18818801179
Email
zhinan.yin@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Yangzhe Wu, Ph.D.
Phone
(+86)18826469480
Email
190374157@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guofang Deng, Master
Organizational Affiliation
Partner
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shenzhen Third People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoliang Zhang, Ph.D
Phone
(+86)13823317076
Email
szdsyy@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Guofang Deng, Master
Phone
(+86)13530027001
Email
jxxk1035@yeah.net

12. IPD Sharing Statement

Citations:
PubMed Identifier
34975844
Citation
Liang J, Fu L, Li M, Chen Y, Wang Y, Lin Y, Zhang H, Xu Y, Qin L, Liu J, Wang W, Hao J, Liu S, Zhang P, Lin L, Alnaggar M, Zhou J, Zhou L, Guo H, Wang Z, Liu L, Deng G, Zhang G, Wu Y, Yin Z. Allogeneic Vgamma9Vdelta2 T-Cell Therapy Promotes Pulmonary Lesion Repair: An Open-Label, Single-Arm Pilot Study in Patients With Multidrug-Resistant Tuberculosis. Front Immunol. 2021 Dec 15;12:756495. doi: 10.3389/fimmu.2021.756495. eCollection 2021.
Results Reference
derived

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

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