RECRUITINGPhase 4

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

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.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

30 participants

Sites

2 locations

Start Date

August 2022

Completion

August 2025

MDR-TBImmunotherapyVγ2Vδ2 T lymphocyte-based immunotherapyTreatment regimens for MDR-TB

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

5.0 years

total trial span

Rate

pts/month needed

Aug 2022Month 50 of 60Aug 2025

83% of trial timeline elapsed10 months to primary endpoint

At 2 sites, each site needs to enroll approximately 0.5 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

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.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

RECRUITINGPhase 4

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

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.

Sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Enrollment

30 participants

Sites

2 locations

Start Date

August 2022

Completion

August 2025

MDR-TBImmunotherapyVγ2Vδ2 T lymphocyte-based immunotherapyTreatment regimens for MDR-TB

Enrollment & Timeline

Recruiting

Target enrollment (estimated)

Target N

participants

Sites

locations

Duration

5.0 years

total trial span

Rate

pts/month needed

Aug 2022Month 50 of 60Aug 2025

83% of trial timeline elapsed10 months to primary endpoint

At 2 sites, each site needs to enroll approximately 0.5 patients/month to hit the enrollment target on schedule.

Enrollment target is estimated. ClinicalTrials.gov does not provide real-time enrollment progress.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

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.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

No linked publications found in PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

all

Healthy Volunteers

View full criteria

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.

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

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

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

Enrollment & Timeline

Primary Outcomes

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Eligibility

Trial Sites (2)