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Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease

Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease. Two Doses Phase II, Single Center, Open-label Trial

NCT04154826•Revimmune

View on ClinicalTrials.gov

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).

Detailed 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

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged ≥18 years but \<85 years who have given written informed consent to participate
•2. Diagnosis of pulmonary nontuberculous mycobacterial lung disease in accordance with the 2007 Infectious DiseasesSociety of America (IDSA) and AmericanThoracic Society (ATS) criteria with evidence of nodular bronchiectatic and/or cavitary disease by chest CT
•3. History of chronic, refractory infection with either Mycobacterium avium complex, defined as:
•1. Persistently positive mycobacterial sputum cultures after 6 or more months of guideline-based treatment (GBT), with at least one positive sputum culture within 2 months prior to the baseline visit and
•2. Currently on a stable guideline-based therapy that has been unchanged for the past 28 days. (GBT defined as a multi-drug regimen containing a macrolide and at least one other antimicrobial with activity against NTM.)
•4. Ability to produce at least 3 mL of sputum or be willing to undergo an induction to produce at least 3 mL of sputum for clinical evaluation
•5. This study permits the re-enrollment of a participant who may have been discontinued as a pre-treatment screen failure prior to study drug treatment.
•6. Age and reproductive status:
•1. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment
•2. Women must not be breastfeeding
+4 more criteria

Exclusion Criteria

•1. Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 months). All patients with current, or history of, hematologic malignancy (including, but not limited to, acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), chronic myeloid leukemia (CML), etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy
•2. Active pulmonary tuberculosis requiring concomitant treatment at the time of screening
•3. Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
•4. Patients who have received solid organ transplant or bone marrow transplant
•5. Known history of infection with HIV or HIV positive test at screening
•6. Known history of chronic HBV (hepatitis B viral) infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization or HBV DNA \> 100 IU/mL
•7. Known history of infection with HCV (hepatitis C virus) and currently undergoing treatment for HCV infections or has detectable HCV RNA
•8. History of splenectomy
•9. Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia
•10. Significant liver or renal dysfunction as evidence by at least 5 times greater than the upper limits of normal baseline ALT (alanine aminotransferase), AST (aspartate aminotransferase), alkaline phosphatase, or total bilirubin.
+10 more criteria

Locations (1)

Washington University

St Louis, Missouri, United States

Key Dates

Start Date

November 30, 2020

Primary Completion Date

December 31, 2023

Completion Date

March 30, 2024

Last Updated

April 11, 2024

Enrollment

ACTUAL participants

Conditions

Mycobacterium Infections, Nontuberculous

Interventions

Recombinant human interleukin-7

DRUG

Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)

NCT07094711

Mycobacterium Avium-intracellulare InfectionMycobacterium Infections, Nontuberculous

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COMPLETEDPHASE2

Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection

NCT03421743

Mycobacterium Infections, Nontuberculous

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease

Inclusion Criteria

Exclusion Criteria

Safety, Immunogenicity, and Efficacy of Therapeutic Mycobacterium Bovis BCG (BOOST)

Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection

Diagnostic Accuracy of Nontuberculous Mycobacterial Lung Disease Based on Chest CT