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

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.
• •11. Evidence of biliary cirrhosis with portal hypertension
• •12. Participation in another investigational interventional study testing a drug or a medical device concurrently or within the last 28 days prior to study entry
• •13. Patients receiving immunosuppressive drugs or concurrent immunotherapy or biologic agents; including: growth factors, cytokines and interleukins other than the study medication: Interleukin-2, Interferons α, β and γ, GM-CSF, G-CSF (colony stimulating factors), HIV vaccines, biologics including TNF alpha inhibitors (i.e. abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, ixekizumab, natalizumab, rituximab, secukinumab, tocilizumab, ustekinumab, vedolizumab, basiliximab and daclizumab), calcineurin inhibitors, mammalian target of rapamycin inhibitors, inosine monophosphate dehydrogenase inhibitors, Janus kinase inhibitors, hydroxyurea, immunoglobulins, adoptive cell therapy
• •14. Patients receiving corticosteroids at a dose greater than 300mg hydrocortisone/ day or 25 mgs of prednisone per day or equivalent for more than 3 weeks
• •15. Prior exposure to exogenous IL 7
• •16. Inability to comply with the study treatment, study visits, and study procedures as assessed by the study PI or delegate
• •17. Subjects with hemoptysis of ≥60 mL in a 24 hour period within 4 weeks prior to screening
• •18. Addition of any new antimicrobial drug with known activity against Mycobacterium avium complex infection (i.e. amikacin, azithromycin, bedaquiline, clarithromycin, ciprofloxacin, clofazimine, ethambutol, eravacycline, levofloxacin, linezolid, moxifloxacin, omadacycline, rifampin, rifabutin, tedizolid, tigecycline tobramycin) within 28 days prior to Study Day 1
• •19. Daily continuous oxygen supplementation \>4 L/min
• •20. Patients unlikely to survive a minimum of 30 days defined by (Systolic blood pressure) SBP\<90 or hypoxia \<80% SpO2 (oxygen saturation) -