Interleukin-7 for Nontuberculous Mycobacterial Infections

(IMPULSE-7 Trial)

No longer recruiting at 1 trial location

Overseen By Michel MORRE, DVM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Revimmune

Must be taking: Macrolides, Antimicrobials

Must not be taking: Immunosuppressants, Biologics

Disqualifiers: Cancer, Autoimmune diseases, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called recombinant Interleukin-7 (IL-7) for individuals with stubborn lung infections caused by nontuberculous mycobacteria. Researchers aim to assess the safety and effectiveness of IL-7 and understand how the body processes it. The study includes two groups receiving different doses to compare results. It may suit those who continue to struggle with this infection despite ongoing treatment and can provide a sputum sample for testing. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial requires that you continue your current guideline-based therapy for nontuberculous mycobacterial lung disease, as it must be stable and unchanged for the past 28 days. However, you cannot add any new antimicrobial drugs with activity against Mycobacterium avium complex within 28 days before starting the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that recombinant human interleukin-7 (CYT107) is generally safe for people. A safety study found no serious risks with this treatment and no harmful chemicals at the doses tested. Another study on patients with sepsis found that CYT107 was safe, even with repeated use.

These results suggest that recombinant interleukin-7 is safe for humans at the studied doses. However, like any treatment, it might still cause side effects. Participants should inform their healthcare providers about any unusual symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Recombinant human interleukin-7 (CYT107) is unique because it boosts the immune system differently than standard antibiotics used to treat refractory nontuberculous mycobacterial lung disease. Unlike traditional treatments that directly target the bacteria, CYT107 enhances the body's own immune response by stimulating T-cells, potentially leading to a more effective and sustained fight against the infection. Researchers are excited about CYT107 because it offers a novel approach that could improve outcomes for patients who don't respond well to existing therapies, providing a new avenue for treatment where options are currently limited.

What evidence suggests that recombinant human interleukin-7 could be an effective treatment for refractory nontuberculous mycobacteria lung disease?

Research has shown that recombinant human interleukin-7 (IL-7) can aid the immune system by boosting T-cell recovery, crucial for fighting infections. In people with HIV, studies have found that IL-7 increases T-cell numbers and enhances immune recovery without causing serious side effects in patients undergoing certain stem cell transplants. This trial will evaluate IL-7 at different dosages, with one group receiving a low dose and another a high dose, to determine its potential to strengthen the immune system in patients with difficult-to-treat lung infections. ^{1 5 6 7 8}

Who Is on the Research Team?

Andrej SPEC, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

Inclusion Criteria

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

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

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.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CYT107 at either 10µg/kg/week or 20µg/kg/week for two 4-week treatment periods with a 4-week break in between

12 weeks

Weekly visits for drug administration

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of sputum culture conversion and health-related quality of life

6 months

Visits at days 28, 56, 84, 180, 300, and 360

Open-label extension (optional)

Potential study extension in the United Kingdom to increase enrollment and participating centers

What Are the Treatments Tested in This Trial?

Interventions

• Recombinant human interleukin-7

How Is the Trial Designed?

Group I: low dose Experimental Treatment 1 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 dose Experimental Treatment 1 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)

Who Is Running the Clinical Trial?

Revimmune

Lead Sponsor

Trials

11

Recruited

210+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

Interleukin-7 (IL-7) is crucial for the growth and survival of T-lymphocytes, making it a promising treatment option for immunodeficiencies caused by T-cell loss due to diseases like HIV or treatments like chemotherapy.

While IL-7 can help restore T-cell levels in lymphopenia, it may also contribute to autoimmune diseases, suggesting that blocking IL-7 could be beneficial in conditions like Rheumatoid Arthritis and Multiple Sclerosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IL-7 and lymphopenia. Ponchel, F., Cuthbert, RJ., Goëb, V.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10008152/

a double-blind, randomized, placebo-controlled trial - PMC Effects of recombinant human interleukin 7 on T-cell recovery and thymic output in HIV-infected patients receiving antiretroviral therapy: ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03821038?term=AREA%5BBasicSearch%5D(REVIMMUNE)&rank=5

Recombinant Interleukin-7 (CYT107) to Restore Absolute ... A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3520625/

Recombinant human interleukin-7 (CYT107) promotes T-cell ... Our results indicate that r-hIL-7 can enhance immune recovery after a T cell–depleted allo-HSCT without causing significant GVHD or other serious toxicity (www.

4. insight.jci.org insight.jci.org/articles/view/189150

A randomized, double-blind, placebo-controlled trial of IL-7 ... Results demonstrated that recombinant human IL-7 (CYT107), which potently enhances adaptive immunity, did not precipitate a cytokine storm ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00839436

Interleukin-7 (CYT107) Treatment of Idiopathic CD4 ... A first-generation form of rhIL-7 was shown in pre-clinical and Phase I studies in oncology and human immunodeficiency virus (HIV)-infected patients to be well ...

6. media.cellsignal.com media.cellsignal.com/www/pdfs/resources/msds/8170_hil7_MSDS.pdf

Material Safety Data Sheet (MSDS) for Human Interleukin- ... EMERGENCY OVERVIEW: OSHA: No known hazards. This substance is not classified as dangerous according to Directive 67/548/EEC. III. Composition/Information:.

7. akronbiotech.com akronbiotech.com/assets/files/AR1013-SDS-rHu-IL-7-CSS.pdf

Recombinant Human Interleukin-7 (rHu IL-7), Closed ... Mixture. This product contains no substances which are considered hazardous to health at their given concentrations. Chemical Name.

8. stemcell.com stemcell.com/products/human-recombinant-il-7.html

Human Recombinant IL-7 Safety Data Sheet. Product Name. Human Recombinant IL-7. Catalog #. 78053.3, 78053.1, 78053. Lot #. All. Language. English. View More View Less. Applications.