Actively Recruiting
Exploratory Study of Vb32Vb42 T Lymphocyte-based Immunotherapy Combined with Anti-Tuberculosis Chemotherapy for MDR-TB
Led by Shanghai Pulmonary Hospital, Shanghai, China · Updated on 2022-08-10
30
Participants Needed
2
Research Sites
104 weeks
Total Duration
On this page
Sponsors
S
Shanghai Pulmonary Hospital, Shanghai, China
Lead Sponsor
S
Shanghai Public Health Clinical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a combination of zoledronic acid and interleukin 2 that boosts a specific immune cell subset called Vb32Vb42 T cells, alongside standard anti-tuberculosis chemotherapy, to treat multidrug-resistant tuberculosis (MDR-TB). MDR-TB is a serious form of drug-resistant TB with limited cure rates despite current treatments. This study explores immunotherapy as a new approach to help patients who respond poorly to existing drug regimens. Participants receive treatment following WHO guidelines for drug-resistant TB. One group gets standard MDR-TB treatment plus intravenous zoledronic acid three times and subcutaneous recombinant human interleukin 2 ten times over six months. The other group receives only the standard MDR-TB treatment regimen. The immunotherapy aims to expand and activate Vb32Vb42 T cells to better fight the infection. During the study, researchers monitor participants for changes in sputum smear and culture results, with an average follow-up of 24 months. They also assess lung changes through radiographic imaging over this period. The study collects data on immune response and treatment effectiveness while following participants closely to evaluate safety and disease progression from start to completion.
CONDITIONS
Brief Title
A Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosis of rifampicin-resistant or multidrug-resistant tuberculosis
- Poor response or no response to previous tuberculosis treatment
- Currently on fewer than four effective anti-tuberculosis drugs
You will not qualify if you...
- Immunosuppression due to conditions such as immune system disorders or tumors
- Confirmed poor response to zoledronic acid and interleukin 2 stimulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive treatment according to WHO guidelines for multidrug-resistant tuberculosis; those in the experimental group also receive intravenous zoledronic acid 3 times and subcutaneous recombinant human interleukin 2 injections 10 times over 6 months.
Multiple visits during 6 months of treatment
Duration - Up to 18 months after treatment completion, totaling approximately 24 months from start
Participants are monitored for sputum smear and culture conversion as well as radiographic changes to assess treatment response and long-term outcomes.
Periodic visits during follow-up up to study completion
Trial Site Locations
Total: 2 locations
1
Shanghai Pulmonary Hospital, Shanghai, China
Shanghai, China, 200433
Actively Recruiting
2
Shanghai Pulmonary Hospital
Shanghai, China
Actively Recruiting
Research Team
S
Sha Wei
L
Liu Yidian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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