NCT05493267

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
15mo left

Started Aug 2022

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Aug 2022Aug 2027

First Submitted

Initial submission to the registry

August 3, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

August 3, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 9, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2027

Expected
Last Updated

August 10, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

August 3, 2022

Last Update Submit

August 8, 2022

Conditions

MDR-TBImmunotherapy

Keywords

MDR-TB；Immunotherapy；

Outcome Measures

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.

    Through study completion, an average of 24 months.

Secondary Outcomes (1)

  • Radiographic changes

    Through study completion, an average of 24 months.

Other Outcomes (3)

  • Treatment outcome

    Through study completion, an average of 24 months.

  • Adverse reactions

    Through study completion, an average of 24 months.

  • Immunological indicators

    Through study completion, an average of 24 months.

Study Arms (2)

Vγ2Vδ2 T lymphocyte-based immunotherapy +Treatment regimens for MDR-TB

EXPERIMENTAL

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

Drug: Vγ2Vδ2 T lymphocyte-based immunotherapyDrug: Treatment regimens for MDR-TB

Treatment regimens for MDR-TB

ACTIVE COMPARATOR

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

Drug: Treatment regimens for MDR-TB

Interventions

Vγ2Vδ2 T lymphocyte-based immunotherapyDRUG

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.

Also known as: Drug combination (zoledronic acid/interleukin 2)
Vγ2Vδ2 T lymphocyte-based immunotherapy +Treatment regimens for MDR-TB
Treatment regimens for MDR-TBDRUG

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

Also known as: Treatment regimen for MDR-TB using WHO guidelines
Treatment regimens for MDR-TBVγ2Vδ2 T lymphocyte-based immunotherapy +Treatment regimens for MDR-TB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Shanghai Pulmonary Hospital, Shanghai, China

Shanghai, 200433, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

Drug CombinationsClinical Protocols

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Central Study Contacts

Sha Wei

CONTACT

+860216511500613671758200@126.com

Liu Yidian

CONTACT

+860216511500613816676933@139.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Tuberculosis Department,Shanghai Pulmonary Hospital, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 9, 2022

Study Start

August 3, 2022

Primary Completion

August 3, 2025

Study Completion (Estimated)

August 3, 2027

Last Updated

August 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)