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

(IMPULSE-7 Trial)

Overseen By Michel MORRE, DVM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Revimmune

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

8 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Recombinant human interleukin-7?

Recombinant human interleukin-7 (rhIL-7) has shown promise in boosting the immune system by helping T-cells grow and survive, which is important for people with weakened immune systems, such as those undergoing chemotherapy or with HIV. Studies suggest it can help improve immune recovery and may be useful in cancer immunotherapy by promoting T-cell expansion and countering immune suppression. ^{1 2 3 4 5}

Is recombinant human interleukin-7 (rhIL-7) generally safe for humans?

Recombinant human interleukin-7 (rhIL-7) has been studied for its safety in humans, particularly in those with immune system issues like cancer and HIV. While it shows promise in boosting immune function, there are concerns about potential risks such as increased viral infections, autoimmunity, and cancer, which need further research to fully understand. ^{1 3 5 6 7}

How does the drug recombinant human interleukin-7 differ from other treatments for immune system conditions?

Recombinant human interleukin-7 (rhIL-7) is unique because it specifically promotes the development and survival of T and B cells, which are crucial for a healthy immune system. Unlike other treatments, rhIL-7 can enhance immune function in various conditions, including those with weakened immune systems due to age, disease, or treatments like chemotherapy, by expanding T cell populations and counteracting immune suppression. ^{1 3 4 8 9}

Research Team

Andrej SPEC, MD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

Males and females aged ≥18 years but <85 years who have given written informed consent to participate

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

Timeline

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

Treatment Details

Interventions

• Recombinant human interleukin-7

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Phase I study of recombinant human interleukin-7 administration in subjects with refractory malignancy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

IL-7 and lymphopenia. [2016]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Mechanism of Action of IL-7 and Its Potential Applications and Limitations in Cancer Immunotherapy. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a continuous IL-7-dependent murine pre-B cell line PB-1 suitable for the biological characterisation and assay of human IL-7. [2019]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

The IL-7/IL-7 receptor axis: understanding its central role in T-cell homeostasis and the challenges facing its utilization as a novel therapy. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

The Broad Immunomodulatory Effects of IL-7 and Its Application In Vaccines. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Risk of Infections and Cancer in Patients With Rheumatologic Diseases Receiving Interleukin Inhibitors: A Systematic Review and Meta-analysis. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The biological role and potential therapeutic application of interleukin 7. [2006]

9. United States pubmed.ncbi.nlm.nih.gov

Expression, purification, and functional characterization of recombinant human interleukin-7. [2016]