- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03575299
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells (MDR-TB)
June 29, 2018 updated by: Zhinan Yin, Ph.D.
Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
Brief summary: Allogeneic γδT cells from healthy donor will be administrated intravenously to patients with the MDR-TB,and then the safety and efficacy of γδT cells will be evaluated.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
All patients with multi-drug resistant pulmonary tuberculosis will be assigned into 2 groups(study group and control group),both groups will receive conventional treatment.
Allogeneic γδT cell will be administrated intravenously to patients in the study group (but not the control group) every two weeks for 6 months
Study Type
Interventional
Enrollment (Anticipated)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zhinan Yin, Ph.D.
- Phone Number: (+86)18818801179
- Email: zhinan.yin@yale.edu
Study Contact Backup
- Name: Yangzhe Wu, Ph.D.
- Phone Number: (+86)18826469480
- Email: 190374157@qq.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- Recruiting
- Shenzhen Third People's Hospital
-
Contact:
- Guoliang Zhang, Ph.D
- Phone Number: (+86)13823317076
- Email: szdsyy@yahoo.com.cn
-
Contact:
- Guofang Deng, Master
- Phone Number: (+86)13530027001
- Email: jxxk1035@yeah.net
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 18-50 years old, male or female;
- Informed consent;
- Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.
Exclusion Criteria:
- AIDS, hepatitis B and other viruses, bacterial infections;
- Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
- Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
- Those who do not agree to be included.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.
|
Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
|
Placebo Comparator: Control Group
Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.
|
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
No allogeneic γδT cells will be administered to patients with MDR-TB.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
sputum smear
Time Frame: 6 months
|
The sputum specimens will be collected biweekly in the first 2 months and bimonthly thereafter for sputum smear to study the time (months) of the sputum conversion.
The sputum conversation rate will be analyzed at the end of study.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sputum tubercle bacillus culture
Time Frame: 6 months
|
The sputum specimens will be collected for culture to detect the TB biweekly in the first 2 months and bimonthly thereafter to study the time (months) of the sputum conversion.
The sputum conversation rate will be analyzed at the end of study.
|
6 months
|
Fecal microbiome analysis
Time Frame: 6 months
|
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
|
6 months
|
Assessment of immune function
Time Frame: 6 months
|
Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Guofang Deng, Master, Partner
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Anticipated)
June 30, 2021
Study Completion (Anticipated)
December 31, 2021
Study Registration Dates
First Submitted
June 19, 2018
First Submitted That Met QC Criteria
June 29, 2018
First Posted (Actual)
July 2, 2018
Study Record Updates
Last Update Posted (Actual)
July 2, 2018
Last Update Submitted That Met QC Criteria
June 29, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GDT-MDR-TB-069
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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