Clinical Trials Logo

Clinical Trial Summary

A prospective, single-center, single-blinded study involving patients with refractory nontuberculous mycobacteria lung disease to ascertain pharmacokinetics, safety, efficacy, and tolerability of two dose levels of parenteral administration of recombinant Interleukin-7 (IL-7) (CYT107).


Clinical Trial Description

A single center, randomized, phase II, single blinded, two-dose level trial aimed at testing anti-mycobacterial activity of CYT107 in patients with non-tuberculous mycobacteria lung disease (NTMLD). A total of 12 evaluable NTMLD patients from Washington University School of Medicine in St. Louis will be recruited and randomized 6:6 to study drug treatment at either 10μg/kg/wk or 20μg/kg/wk for two 4-week treatment periods. The randomization will be stratified based on the presence of pulmonary cavitaries. A maximum of three patients with pulmonary cavitary disease will be allocated to each group. A potential study extension is envisioned in the United Kingdom, in which case the protocol would be amended to increase the targeted enrollment and number of participating centers. The aim of this trial is detection of an immuno-therapeutic response in patients with refractory NTMLD and to determine the potential rate of response and tolerance of CYT107 using two dose levels that indicated good immune response in other pathologies such as HIV, HCV, sepsis and various cancers. For patients with refractory NTMLD, a control group is not beneficial as the standard of care treatment results are already known and documented. All serious adverse events (SAEs) will be reported within 24 hours of notification ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04154826
Study type Interventional
Source Revimmune
Contact
Status Terminated
Phase Phase 2
Start date November 30, 2020
Completion date March 30, 2024

See also
  Status Clinical Trial Phase
Completed NCT03038178 - Liposomal Amikacin for Inhalation (LAI) in the Treatment of Mycobacterium Abscessus Lung Disease Phase 2
Active, not recruiting NCT04922554 - Oral Omadacycline vs. Placebo in Adults With NTM Pulmonary Disease Caused by Mycobacterium Abscessus Complex (MABc) Phase 2
Completed NCT02344004 - Study to Evaluate Efficacy of LAI When Added to Multi-drug Regimen Compared to Multi-drug Regimen Alone Phase 3
Recruiting NCT06266442 - M. Avium WGS During Mav-PD Treatment
Recruiting NCT02355015 - A Prospective Registry For Non Tuberculous Mycobacterial (NTM) Infections N/A
Completed NCT03421743 - Pilot Trial of Inhaled Molgramostim in Nontuberculous Mycobacterial (NTM) Infection Phase 2
Not yet recruiting NCT06418711 - ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension Phase 3
Terminated NCT03597347 - Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection Phase 2
Completed NCT02832843 - Genome-Wide Association Study in Patients With Nontuberculous Mycobacterial Lung Disease
Completed NCT04677543 - Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex Phase 3
Completed NCT02340897 - Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT N/A
Completed NCT01315236 - Liposomal Amikacin for Inhalation (LAI) for Nontuberculous Mycobacteria Phase 2
Recruiting NCT04677569 - Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex Phase 3