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

Phase 1

• Conditions: Multi-drug Resistant Tuberculosis
• Interventions: Other: Control; Biological: The adoptive treatment of allogeneic γδT cells; Drug: Conventional treatment

• Registration Number: NCT03575299
• Lead Sponsor: Zhinan Yin, Ph.D.

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

Study Timeline

• Status Verified: 2018-06
• Study Start: 2018-06-01
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-29
• Last Update Submitted: 2018-06-29
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-02
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control	Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
Study group	The adoptive treatment of allogeneic γδT cells	Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
Study group	Conventional treatment	Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
Control Group	Conventional treatment	Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.

Primary Outcome Measures

Name	Time	Method
sputum smear	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

Name	Time	Method
Assessment of immune function	6 months	Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .
Fecal microbiome analysis	6 months	The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
Sputum tubercle bacillus culture	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.

Trial Locations

Locations (1)

Shenzhen Third People's Hospital; 🇨🇳 Shenzhen, Guangdong, China