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

Zhinan Yin, Ph.D.

Status and phase: Unknown; Phase 1

Conditions: Multi-drug Resistant Tuberculosis

Treatments: Biological: The adoptive treatment of allogeneic γδT cells; Drug: Conventional treatment; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03575299

GDT-MDR-TB-069

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups, including a placebo group

Study group

Experimental group

Description:

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

Treatment:

Biological: The adoptive treatment of allogeneic γδT cells

Drug: Conventional treatment

Control Group

Placebo Comparator group

Description:

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

Treatment:

Other: Control

Drug: Conventional treatment