RecruitingPhase 4NCT05493267

A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

30 participants

Start Date

Aug 3, 2022

Study Type

INTERVENTIONAL

Conditions

Immunotherapy MDR-TB

Summary

A Exploratory Study of drug combination (zoledronic acid/interleukin 2) that specifically amplifies Vγ2Vδ2 T cells in combination with anti-tuberculosis chemotherapy for the treatment of MDR-TB.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

RR-TB/MDR-TB (resistant to at least isoniazid and rifampicin).
Poor efficacy of the original treatment regimen or no response to treatment or less than 4 effective drugs.

Exclusion Criteria2

Immunosuppression due to co-morbidities, such as immune system disorders, tumors, etc.
Test confirms poor response to ZOL and IL-2 stimulation.

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Interventions

DRUGVγ2Vδ2 T lymphocyte-based immunotherapy

Intravenous injection of zoledronic acid, followed by a subcutaneous injection recombinant human interleukin. Zoledronic acid was administered 3 times and recombinant human interleukin was administered 10 times for a total of 6 months.

DRUGTreatment regimens for MDR-TB

Treatment regimens was based on the principles of the WHO guidelines for the treatment of drug-resistant tuberculosis.