Recombinant human interleukin-7 for Mycobacterium abscessus Infection

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mycobacterium abscessus Infection+2 More
Recombinant human interleukin-7 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Mycobacterium abscessus Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 12 Secondary · Reporting Duration: one year

1 year
Measure of CYT107 immunogenicity
2 months
IL-7 Effects on circulating cytokines
IL-7 Effects on immune T cell markers
3 months
IL-7 Effects on cellular cytokine production
One day
C max (maximal plasma concentration) pharmacokinetic of CYT107 in this population
Plasma concentration area under curve (AUC) pharmacokinetic of CYT107 in this population
one year
Efficacy by kinetic of AFB sputum culture conversion to negative.
IL-7 Effects on CD4+ and CD8+ T lymphocytes
IL-7 Effects on immune cells counts
IL-7 effect on opportunistic bacterial, viral or fungal infections
Improvement of Health-related Quality of Life (HRQoL)
Improvement of functional capacity response assessed by the median change in oxygen saturation compared to baseline.
Improvement of functional capacity response assessed by the median change in the 6-minute walk distance compared to baseline.
Number of hospital readmissions
Proportion of patients developing any grade 3-4 adverse events or deaths
Pulmonary function response measured by the median improvement in the Forced expiratory volume during the first second (FEV1).
Cognitive Therapy
six months
Clinical tolerance of CYT107 indicated by the study drop-out rate (%) regardless of the cause.
Determination of the proportion of subjects with Acid Fast Bacilli (AFB) sputum culture conversion to negative at day 180.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

low dose
1 of 2
high dose
1 of 2

Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Recombinant human interleukin-7 · No Placebo Group · Phase 2

low dose
Drug
Experimental Group · 1 Intervention: Recombinant human interleukin-7 · Intervention Types: Drug
high dose
Drug
Experimental Group · 1 Intervention: Recombinant human interleukin-7 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: one year

Who is running the clinical trial?

RevimmuneLead Sponsor
9 Previous Clinical Trials
173 Total Patients Enrolled
Washington University School of MedicineOTHER
1,792 Previous Clinical Trials
2,274,463 Total Patients Enrolled
Andrej SPEC, MDPrincipal InvestigatorWashington University School of Medicine

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
in the study People aged 18 to 85 who have given written consent to participate in a study are eligible to participate in the study.
Women who could potentially get pregnant must have a negative pregnancy test within 24 hours of starting the study treatment.
Women who could potentially become pregnant must agree to use a method of birth control for the entire time they are taking CYT107, plus 5 half-lives of CYT107 (which is up to 2 days), plus 30 days (the length of a typical ovulatory cycle) for a total of 2 months after they have finished taking CYT107.
This study allows a participant who may have been discontinued as a pre-treatment screen failure to be re-enrolled.
Males who are sexually active with WOCBP must agree to use contraception during treatment with CYT107 plus 5 half-lives of CYT107 plus 90 days (duration of sperm turnover) for a total of 7 months post-treatment completion
The patient is currently on a stable guideline-based therapy that has not changed for the past 28 days
in public Women are not allowed to breastfeed in public.
You have a positive sputum culture for Mycobacterium tuberculosis after 6 months of GBT, with at least one positive sputum culture within 2 months prior to the baseline visit.
You are able to produce at least 3 mL of sputum or you are willing to undergo an induction to produce at least 3 mL of sputum for clinical evaluation.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.