NCT03575299

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 2, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

June 19, 2018

Last Update Submit

June 29, 2018

Conditions

Multi-drug Resistant Tuberculosis

Keywords

MDR-TBAllogeneic γδT cellsadoptive treatment

Outcome Measures

Primary Outcomes (1)

  • sputum smear

    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 Outcomes (3)

  • Sputum tubercle bacillus culture

    6 months

  • Fecal microbiome analysis

    6 months

  • Assessment of immune function

    6 months

Study Arms (2)

Study group

EXPERIMENTAL

Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells.

Biological: The adoptive treatment of allogeneic γδT cellsDrug: Conventional treatment

Control Group

PLACEBO COMPARATOR

Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells.

Other: ControlDrug: Conventional treatment

Interventions

The adoptive treatment of allogeneic γδT cellsBIOLOGICAL

Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.

Study group
ControlOTHER

No allogeneic γδT cells will be administered to patients with MDR-TB.

Control Group
Conventional treatmentDRUG

Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.

Control GroupStudy group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518000, China

RECRUITING

Related Publications (1)

  • Liang J, Fu L, Li M, Chen Y, Wang Y, Lin Y, Zhang H, Xu Y, Qin L, Liu J, Wang W, Hao J, Liu S, Zhang P, Lin L, Alnaggar M, Zhou J, Zhou L, Guo H, Wang Z, Liu L, Deng G, Zhang G, Wu Y, Yin Z. Allogeneic Vgamma9Vdelta2 T-Cell Therapy Promotes Pulmonary Lesion Repair: An Open-Label, Single-Arm Pilot Study in Patients With Multidrug-Resistant Tuberculosis. Front Immunol. 2021 Dec 15;12:756495. doi: 10.3389/fimmu.2021.756495. eCollection 2021.

    PMID: 34975844DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Guofang Deng, Master

    Partner

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhinan Yin, Ph.D.

CONTACT

(+86)18818801179zhinan.yin@yale.edu

Yangzhe Wu, Ph.D.

CONTACT

(+86)18826469480190374157@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dean of Biomedical Translational Research Institute，jinan University

Study Record Dates

First Submitted

June 19, 2018

First Posted

July 2, 2018

Study Start

June 1, 2018

Primary Completion

June 30, 2021

Study Completion

December 31, 2021

Last Updated

July 2, 2018

Record last verified: 2018-06

Locations

CN(1)