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

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

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:
        • Contact:

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:

  1. Aged 18-50 years old, male or female;
  2. Informed consent;
  3. Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.

Exclusion Criteria:

  1. AIDS, hepatitis B and other viruses, bacterial infections;
  2. Patients with other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system diseases, mental diseases, neurological diseases, and vascular circulatory diseases;
  3. Others After being evaluated by clinicians participating in this project, it is not suitable to participate in immune cell therapy;
  4. 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.

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

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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