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Cytokine

Recombinant human interleukin-7 for Nontuberculous Mycobacterial Infections (IMPULSE-7 Trial)

Phase 2
Waitlist Available
Led By Andrej SPEC, MD
Research Sponsored by Revimmune
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a lab-made protein called Interleukin-7 to help boost the immune system in patients with hard-to-treat lung disease caused by non-tuberculous mycobacteria. Interleukin-7 has been shown to improve specific immune responses and has potential in enhancing the body's ability to fight infections. The goal is to see if this treatment can help their immune system fight the infection better.

Eligible Conditions
  • Nontuberculous Mycobacterial Infections
  • Mycobacterium Abscessus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determination of the proportion of subjects with Acid Fast Bacilli (AFB) sputum culture conversion to negative at day 180.
Secondary study objectives
C max (maximal plasma concentration) pharmacokinetic of CYT107 in this population
Clinical tolerance of CYT107 indicated by the study drop-out rate (%) regardless of the cause.
Efficacy by kinetic of AFB sputum culture conversion to negative.
+9 more
Other study objectives
IL-7 Effects on CD4+ and CD8+ T lymphocytes
IL-7 Effects on cellular cytokine production
IL-7 Effects on circulating cytokines
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: low doseExperimental Treatment1 Intervention
CYT107 10µg/kg/week for 4 weeks (wk1-4) followed by no treatment during 4 weeks (wk 5-8) CYT107 10µg/kg/week for 4 weeks (wk9-12)
Group II: high doseExperimental Treatment1 Intervention
CYT107 20µg/kg/week for 4 weeks (wk1-4) followed by no treatment during 4 weeks (wk 5-8) CYT107 20µg/kg/week for 4 weeks (wk9-12)

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,991 Previous Clinical Trials
2,295,876 Total Patients Enrolled
RevimmuneLead Sponsor
10 Previous Clinical Trials
203 Total Patients Enrolled
Andrej SPEC, MDPrincipal InvestigatorWashington University School of Medicine
~2 spots leftby Nov 2025
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