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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03575299
Other study ID # GDT-MDR-TB-069
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date June 1, 2018
Est. completion date December 31, 2021

Study information

Verified date June 2018
Source Jinan University Guangzhou
Contact Zhinan Yin, Ph.D.
Phone (+86)18818801179
Email zhinan.yin@yale.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date December 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Multi-drug Resistant Tuberculosis
  • Tuberculosis
  • Tuberculosis, Multidrug-Resistant

Intervention

Biological:
The adoptive treatment of allogeneic ?dT cells
Allogeneic ?dT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
Other:
Control
No allogeneic ?dT 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.

Locations

Country Name City State
China Shenzhen Third People's Hospital Shenzhen Guangdong

Sponsors (2)

Lead Sponsor Collaborator
Zhinan Yin, Ph.D. Shenzhen Third People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 6 months
Secondary 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. 6 months
Secondary Fecal microbiome analysis The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter. 6 months
Secondary Assessment of immune function Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic ?dT cells . 6 months
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