A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai Pulmonary Hospital, Shanghai, China
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Immunosuppression due to co-morbidities, such as immune system disorders, tumors, etc.
Test confirms poor response to ZOL and IL-2 stimulation.
Trial design
Design model
Parallel
Treatments tested in this trial
Vγ2Vδ2 T lymphocyte-based immunotherapy
DrugIntravenous 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
DrugTreatment regimens was based on the principles of the WHO guidelines for the treatment of drug-resistant tuberculosis.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Vγ2Vδ2 T lymphocyte-based immunotherapy +Treatment regimens for MDR-TBExperimental treatment 2 interventions
Group B: Treatment regimens for MDR-TBActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sputum smear and culture negative conversion
Sputum smear microscopy, bacterial culture. Bacterial culture was performed via a mycobacterial growth indicator tube (MGIT) using the BACTEC MGIT 960 system.
Time frame
Through study completion, an average of 24 months.Secondary outcomes
1
Radiographic changes
Radiographic changes after treatment compared to baseline.Outcomes were defined as unchanged or deteriorated; ecovered; improved based on radiological findings compared to baseline.
Time frame
Through study completion, an average of 24 months.Other outcomes
1
Treatment outcome
Treatment outcome assessed at the end of the treatment course according to the new definitions released by the WHO.Classified as Treatment success (cure, treatment completion); Treatment failure, Death, Loss, Inconclusive.
Time frame
Through study completion, an average of 24 months.2
Adverse reactions
Adverse reactions to drugs: Number of patients with Grade 3 or 4 Adverse Events，using a Modified Division of Acquired Immunodeficiency Syndrome National Institute of Allergy and Infectious Diseases \[DAIDS\] Scale of Adverse Event Reporting
Time frame
Through study completion, an average of 24 months.3
Immunological indicators
The ability of Vγ2Vδ2 T cells to produce functional cytokines was analyzed. The results were enhanced/reduced cytokine production.
Time frame
Through study completion, an average of 24 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai Pulmonary Hospital, Shanghai, China
Lead sponsor
Shanghai Public Health Clinical Center
Collaborator
Huashan Hospital
Collaborator
No.85 Hospital, Changning, Shanghai, China
Collaborator
Source ClinicalTrials.gov