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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

IMPULSE-7 Trial Summary

This trial is testing a new treatment for a lung disease caused by nontuberculous mycobacteria. The treatment is a drug called recombinant Interleukin-7 (IL-7), and this trial is testing two different dose levels to see how well it works and if it is safe.

Eligible Conditions

Nontuberculous Mycobacterial Infections

IMPULSE-7 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of the proportion of subjects with Acid Fast Bacilli (AFB) sputum culture conversion to negative at day 180.

Secondary outcome measures

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 outcome measures

IL-7 Effects on CD4+ and CD8+ T lymphocytes

IL-7 Effects on cellular cytokine production

IL-7 Effects on circulating cytokines

+3 more

IMPULSE-7 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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER

1,938 Previous Clinical Trials

2,297,912 Total Patients Enrolled

RevimmuneLead Sponsor

9 Previous Clinical Trials

173 Total Patients Enrolled

Andrej SPEC, MDPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research encompass individuals who are of senior age?

"This clinical trial is seeking individuals who are younger than 85 years old and older than the age of majority."

Answered by AI

What further investigations have been performed with regards to Recombinant human interleukin-7?

"Presently, there are 3 ongoing Recombinant human interleukin-7 clinical trials in progress. None of them have progressed to Phase 3 yet; however, the majority of these studies can be found concentrated around Saint Louis, Missouri with a total of 12 trial sites across the nation."

Answered by AI

Has Recombinant human interleukin-7 been sanctioned for public usage by the FDA?

"A score of 2 was assigned to Recombinant human interleukin-7 as there is evidence for its safety, but no clinical results demonstrating the efficacy of the drug."

Answered by AI

What criteria must potential participants satisfy to be considered eligible for this clinical experiment?

"This clinical trial is enrolling 12 individuals between 18 and 85 who are suffering from a mycobacterium abscessus infection. Furthermore, participants must prospectively be on an unchanging GBT for the past 28 days, not breastfeeding if female, along with being able to expectorate at least 3 mL of sputum or consent to undergoing induction therapy in order to do so. Additionally, former pre-treatment screen failures may re-apply as well."

Answered by AI

To what extent has recruitment been successful for this experiment?

"Affirmative. Per the listing on clinicaltrials.gov, this medical study is presently recruiting patients; it was originally posted November 30th 2020 and has been edited as recently as March 30th 2022. This trial necessitates 12 individuals to be recruited from a single site."

Answered by AI

Has recruitment commenced for this research initiative?

"Clinicaltrials.gov confirms that this medical study is still actively recruiting, having been first posted on November 30th 2020 and last edited on March 30th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2020. "Recombinant Interleukin-7 (CYT107) to Treat Patients With Refractory Nontuberculous Mycobacterial Lung Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04154826.