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

Multi-drug Resistant Tuberculosis Clinical Trial

— MDR-TB  

Official title:

Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03575299
• Other study ID #: GDT-MDR-TB-069
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

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