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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Multi-drug Resistant Tuberculosis

Intervention / Treatment
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* Biological: The adoptive treatment of allogeneic γδT cells
* Other: Control
* Drug: Conventional treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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<br>* Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.<br>Drug: Conventional treatment<br>* Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.<br>|
| Placebo Comparator: Control Group<br>Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells. | Other: Control<br>* No allogeneic γδT cells will be administered to patients with MDR-TB.<br>Drug: Conventional treatment<br>* Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Fecal microbiome analysis | The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter. | 6 months | 
| Assessment of immune function | Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells . | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MDR-TB, Allogeneic γδT cells, adoptive treatment