A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
NCT ID: NCT05493267
Last Updated: 2022-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
30 participants
INTERVENTIONAL
2022-08-03
2027-08-03
Brief Summary
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Detailed Description
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The human immune system plays an important role in the infection, development, treatment and regression of tuberculosis.Mtb is an intracellularly parasitic bacterium that evades host immune clearance.Immunotherapy for TB can kill intracellularly parasitic Mycobacterium tuberculosis, including drug-resistant Mycobacterium tuberculosis, by inducing a host-specific immune response.The combination of antituberculosis chemotherapy and immunotherapy has the potential to open up new avenues for the treatment of multidrug-resistant TB.
In recent years, several studies by our team and others addressing host immune mechanisms have shown that γδ T cells play an important role in the fight against TB infection.Vγ2Vδ2 T cells (also known as Vγ9Vδ2 T cells) are a specific subset of γδ T cells, the only γδ T cells capable of recognizing TB phosphoantigens, and are found only in human and non-human primates.
Our previous study demonstrated that zoledronic acid, an anti-osteoporotic and osteoprotective drug, induced the production of endogenous ligands for Vγ2Vδ2T cells and activated Vγ2Vδ2T cells. Zoledronic acid in combination with interleukin 2 can significantly expand Vγ2Vδ2T cells, and the expanded Vγ2Vδ2T cells can effectively kill intracellular parasitic Mycobacterium tuberculosis, it can also promote the production of more anti-tuberculosis effectors by Vγ2Vδ2T cells and widely stimulate the production of functional cytokines by CD4 and CD8 T cells.
The primate experiments conducted by our team in the ABSL-III laboratory of Wuhan University demonstrated that phosphoantigen/interleukin 2 in a macaque model of tuberculosis infection induced lung phosphoantigen-specific Vγ2Vδ2 T cell expansion and migration, reduced Mycobacterium tuberculosis load in vivo, and effectively improved immune resistance to tuberculosis lung necrosis, demonstrating that targeted Vγ2Vδ2 T cell Immunotherapy of Vγ2Vδ2 T cells has a significant therapeutic effect on TB infection in monkeys , and is also safe for use in macaques. Accordingly, the investigators propose a drug combination (zoledronic acid/interleukin 2) that specifically amplifies Vγ2Vδ2 T cells in combination with anti-tuberculosis chemotherapy for the treatment of multidrug-resistant tuberculosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vγ2Vδ2 T lymphocyte-based immunotherapy +Treatment regimens for MDR-TB
Treatment was based on the principles of the WHO guidelines for the treatment of drug-resistant tuberculosis, with the addition of immunotherapy：zoledronic acid and recombinant human interleukin 2
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.
Treatment regimens for MDR-TB
Treatment regimens was based on the principles of the WHO guidelines for the treatment of drug-resistant tuberculosis.
Treatment regimens for MDR-TB
Treatment regimens was based on the principles of the WHO guidelines for the treatment of drug-resistant tuberculosis.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Poor efficacy of the original treatment regimen or no response to treatment or less than 4 effective drugs.
Exclusion Criteria
* Test confirms poor response to ZOL and IL-2 stimulation.
18 Years
65 Years
ALL
No
Sponsors
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Shanghai Public Health Clinical Center
OTHER_GOV
Huashan Hospital
OTHER
No.85 Hospital, Changning, Shanghai, China
OTHER
Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Wei Sha MD & PhD
Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor
Locations
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Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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L20-209
Identifier Type: -
Identifier Source: org_study_id
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