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

NCT05493267 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Phase

Phase 4

Started

2022-08-03

Last updated

2022-08-10

Condition(s) studied

MDR-TBImmunotherapy

Investigational drug(s) / intervention(s)

Vγ2Vδ2 T lymphocyte-based immunotherapyTreatment regimens for MDR-TB

Vγ2Vδ2 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.

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

Study 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

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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

Primary outcome measure(s)

Sputum smear and culture negative conversion — Through study completion, an average of 24 months.
Sputum smear microscopy, bacterial culture. Bacterial culture was performed via a mycobacterial growth indicator tube (MGIT) using the BACTEC MGIT 960 system.

Trial sites (2)

Facility	City	Region	Status
Shanghai Pulmonary Hospital, Shanghai, China	Shanghai	China	Recruiting
Shanghai Pulmonary Hospital	Shanghai	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05493267 on ClinicalTrials.gov ↗ ← All trials in China