Immunotherapy for multidrug-resistant tuberculosis
A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
PHASE4 · Shanghai Pulmonary Hospital, Shanghai, China · NCT05493267
This study is testing a new immune therapy combined with standard TB treatment to see if it can help people with multidrug-resistant tuberculosis who haven't responded well to current medications.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China (other) |
| Drugs / interventions | chemotherapy, Immunotherapy |
| Locations | 2 sites (Shanghai and 1 other locations) |
| Trial ID | NCT05493267 on ClinicalTrials.gov |
What this trial studies
This study explores the use of Vγ2Vδ2 T lymphocyte-based immunotherapy combined with standard anti-tuberculosis chemotherapy to treat multidrug-resistant tuberculosis (MDR-TB). It aims to enhance the immune response against Mycobacterium tuberculosis, particularly in patients who have shown poor efficacy with existing treatment regimens. The approach involves administering a combination of zoledronic acid and interleukin-2 to amplify specific immune cells that can target drug-resistant TB. By integrating immunotherapy with conventional treatment, the study seeks to improve outcomes for patients with challenging MDR-TB cases.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with MDR-TB who have experienced poor treatment efficacy or have not responded to previous therapies.
Not a fit: Patients with immunosuppression due to co-morbidities or those who have shown poor response to the specific immunotherapy components will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients suffering from multidrug-resistant tuberculosis.
How similar studies have performed: Previous studies have indicated the potential of immunotherapy in treating TB, but this specific approach targeting Vγ2Vδ2 T cells is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai and 1 other locations
- Shanghai Pulmonary Hospital, Shanghai, China — Shanghai, China (RECRUITING)
- Shanghai Pulmonary Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Sha Wei
- Email: 13671758200@126.com
- Phone: +8602165115006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MDR-TB, Immunotherapy, MDR-TB；Immunotherapy；