Multi-drug Resistant TuberculosisPhase 1MDR-TBNCT03575299
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
A Phase 1 study testing The adoptive treatment of allogeneic γδT cells and Conventional treatment in people with Multi-drug Resistant Tuberculosis, run by Zhinan Yin, Ph.D. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- What is being tested?
- The adoptive treatment of allogeneic γδT cells and Conventional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2018to 31 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-50 years old, male or female;
- Informed consent;
- Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shenzhen Third People's Hospital
Shenzhen, Guangdong, 518000
Guoliang Zhang, Ph.D, (+86)13823317076, szdsyy@yahoo.com.cn
Guofang Deng, Master, (+86)13530027001, jxxk1035@yeah.net
About this study
Official title: 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.
Read the 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
- Conditions
- Multi-drug Resistant Tuberculosis
- Being tested
- The adoptive treatment of allogeneic γδT cells, Control, Conventional treatment
- Keywords
- MDR-TB, Allogeneic γδT cells, adoptive treatment
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ControlOther
No allogeneic γδT cells will be administered to patients with MDR-TB.
Conventional treatmentDrug
Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Patients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells. Receives: Biological: The adoptive treatment of allogeneic γδT cells; Drug: Conventional treatment |
| Control Group | Placebo comparator | Patients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells. Receives: Other: Control; Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
Sputum tubercle bacillus culture
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.
Measured: 6 months
Fecal microbiome analysis
The faeces will be taken to study fecal microbiome changes biweekly in the first 2 months, and monthly thereafter.
Measured: 6 months
Assessment of immune function
Peripheral blood will be collected for assessment of immune system function every time before the administration of allogeneic γδT cells .
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start1 Jun 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhinan Yin, Ph.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Third People's Hospital
- Responsible party
- Sponsor-investigator, Zhinan Yin, Ph.D., Jinan University Guangzhou
- Investigators
- Guofang Deng, Master, Principal investigator, Partner
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575299
- Sponsor's protocol ID
- GDT-MDR-TB-069
- Acronym
- MDR-TB
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34975844
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Adoptive Treatment of Multidrug Resistant Pulmonary Tuberculosis With Allogeneic γδT Cells
- ClinicalTrials.gov ID
- NCT03575299
- Acronym / sponsor ID
- MDR-TB / GDT-MDR-TB-069
- Conditions
- Multi-drug Resistant Tuberculosis
- Keywords
- MDR-TB, Allogeneic γδT cells, adoptive treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Zhinan Yin, Ph.D.University, hospital or other
- Collaborators
- Shenzhen Third People's Hospital
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Biological: The adoptive treatment of allogeneic γδT cells, Drug: Conventional treatmentPatients will be treated with anti-tuberculosis drugs, and meanwhile will be treated with Allogeneic γδT cells. |
| Control Group | Placebo comparator | Other: Control, Drug: Conventional treatmentPatients will be treated with anti-tuberculosis drugs, and meanwhile will not be treated with allogeneic γδT cells. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-50 years old, male or female;
- Informed consent;
- Patients with multidrug-resistant tuberculosis diagnosed by positive sputum smear and tubercle bacillus culture.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The adoptive treatment of allogeneic γδT cellsAllogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months. | Biological | Study group |
| ControlNo allogeneic γδT cells will be administered to patients with MDR-TB. | Other | Control Group |
| Conventional treatmentPatients will be treated with anti-tuberculosis drugs throughout the entire process of the study. | Drug | Control Group, Study group |
Primary outcome
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.
3 secondary outcomes
Sputum tubercle bacillus culture
Time frame: 6 months
Fecal microbiome analysis
Time frame: 6 months
Assessment of immune function
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
- Derived from this study: PubMed 34975844Liang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guofang Deng, Master principal investigator
Partner
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The adoptive treatment of allogeneic γδT cells and Conventional treatment in people with Multi-drug Resistant Tuberculosis, run by Zhinan Yin, Ph.D. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhinan Yin, Ph.D. ((+86)18818801179, zhinan.yin@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sputum smear (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575299, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2018.