Allogeneic ?dT cells in pulmonary nontuberculous mycobacterial diseases

Expanded access of allogeneic ?dT cells in pulmonary nontuberculous mycobacterial diseases: phase IIa trial

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900025347

Enrollment

Unknown

Registered

2019-08-24

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

pulmonary nontuberculous mycobacterial disease

Interventions

intervention group:allogeneic ?dT cells, chemotherapeutics

control group:chemotherapeutics

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 years or older, no gender restrictions; (2) According to the US ATS/IDSA 2007 guidelines, diagnosed as NTM-PD, of which the pathogen is Mycobacterium avium, Mycobacterium intracellulare or Mycobacterium abscessus. (3) With or without extrapulmonary NTM; (4) Patients who need clinical intervention after diagnosis; (5) Will not move out of the city during the course of treatment, can follow the plan for follow-up; (6) Women were not pregnant and agreed to use high-efficiency contraception to avoid pregnancy during the study.

Exclusion criteria

Exclusion criteria: (1) Allergic to the study drugs or any of its ingredients; (2) Impaired renal function with serum creatinine 1.5 times the upper limit, or impaired liver function with ALT and/or AST 3 times the upper limit, or hemoglobin less than 7.0 g/dL, or platelets less than 50 x 10^9/L; (3) Diabetes with poor glycemic control; (4) Serious cardiovascular disease, such as heart failure, hypertension with poor blood pressure control, arrhythmia or post-myocardial infarction state; (5) Serious mental illness, alcoholism, drug abuse or other serious diseases; (6) pregnant or lactating women; (7) HIV/AIDS; (8) Karnofsky score <50%; (9) Participated in any other clinical trials within 3 months; (10) NTM-PD not requiring drug intervention; (11) NTM-PD allready started drug treatment for more than 4 weeks; (12) Pathogen of NTM-PD is not Mycobacterium avium, Mycobacteria intracellular, or Mycobacterium abscessus.

Design outcomes

Primary

Measure	Time frame
cure rate;Therapy completion;Recurrence rate;	—

Secondary

Measure	Time frame
Adverse events proportion;culture conversion within 6 months;Macrolide resistance;	—

Countries

China

Contacts

Public ContactLiang Fu

The Second Department of Pulmonary Diseases, Shenzhen Third People's Hospital

flk1981@qq.com+86 15989869571

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026