PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)

Last updated: April 24, 2025
Sponsor: Pulmotect, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Hematologic Neoplasms

Neoplasms

Treatment

Placebo

PUL-042

Clinical Study ID

NCT06665100
PUL-042-207
CP120014
  • Ages > 18
  • All Genders

Study Summary

The purpose of this research study is to try to see whether an experimental drug, PUL 042 Inhalation Solution (PUL 042), is effective in reducing the severity of lung infections in patients with hematologic malignancies and recipients of hematopoietic stem cell transplantation with documented viral infections due to PIV, hMPV, or RSV. PUL-042 or a placebo will be administered 3 times over a 6-day period. The total duration of the study will be approximately 30 days.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects will be eligible for entry into the study if a nasopharyngeal swab ispositive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection withrhinovirus) by molecular assay by a local laboratory AND subjects must fulfill thefollowing inclusion criteria to be eligible for participation in the study:
  1. Subjects with hematologic malignancies (i.e., leukemia, lymphoma, or multiplemyeloma) or recipients of an allogeneic or autologous hematopoietic stem celltransplantation for one of the following diagnoses: leukemia, lymphoma,Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, andmyelodysplastic and myeloproliferative disorder.

  2. Subjects who have undergone active cytotoxic chemotherapy within 6 months orsubjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib,mycophenolate mofetil, corticosteroids ≥1mg/kg prednisone equivalent).

  3. Subjects who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an Immunodeficiency Scoring Index (ISI) ,of greater or equal to 4.

  4. Subjects who are recipients of an autologous HSCT must be within 3 months ofthe transplant procedure.

  5. Subjects must be symptomatic with upper or lower respiratory tract symptomssuch as rhinorrhea, sore throat or cough and must be dosed within 6 days fromthe onset of symptoms.

  6. Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.

  7. Subjects must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.

  8. Spirometry (forced expiratory volume in one second [FEV1] and forced vitalcapacity [FVC]) ≥70% of predicted value.

  9. Adult (≥ 18 years of age).

  10. If female, must be either post-menopausal (one year or greater without menses),surgically sterile, or, for female subjects of child-bearing potential who arecapable of conception must be: practicing two effective methods of birthcontrol (acceptable methods include intrauterine device, spermicide, barrier,male partner surgical sterilization, and hormonal contraception) during thestudy and through 30 days after completion of the study. Abstinence is notclassified as an effective method of birth control.

  11. If female, must not be pregnant, plan to become pregnant, or nurse a childduring the study and through 30 days after completion of the study. A pregnancytest must be negative at the Screening Visit, prior to dosing on Day 1.

  12. If male, must be surgically sterile or willing to practice two effectivemethods of birth control (acceptable methods include barrier, spermicide, orfemale partner surgical sterilization) during the study and through 30 daysafter completion of the study. Abstinence is not classified as an effectivemethod of birth control.

  13. Ability to understand and give informed consent.

Exclusion

Exclusion Criteria:

  • Subjects will be excluded if they fulfill any of the following exclusion criteria:
  1. Patients with a pulse oximetry of hemoglobin saturation less than 93% on roomair.

  2. Known history of chronic pulmonary disease (e.g., asthma [including atopicasthma, exercise-induced asthma, or asthma triggered by respiratory infection],chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension,or heart failure.

  3. Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30days.

  4. Exposure to any investigational agent (defined as any non-FDA-approved agent)within 30 days, or 5 half-lives of the investigational agent, whichever islonger, prior to the Screening Visit.

  5. Allogeneic HSCT recipients with an ISI of 3 or less.

  6. Autologous HSCT recipients more than 3 months after the transplant procedure.

  7. Patients with a relapsed and/or refractory underlying hematologic malignancywith a life expectancy of less than 2 months.

  8. HSCT recipients in the pre-engraftment period.

  9. Chest X-ray with an RSI of >6.

  10. Patients documented to be positive for other respiratory viruses (limited toinfluenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to theScreening Visit, as determined by local testing (additional screening testingis not required).

  11. Clinically significant bacteremia or fungemia within 7 days prior to theScreening Visit that has not been adequately treated, as determined by thePrincipal Investigator.

  12. Any condition which, in the opinion of the Principal Investigator, wouldprevent full participation in this trial or would interfere with the evaluationof the trial endpoints.

  13. Previous exposure to PUL-042 Inhalation Solution.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
April 01, 2025
Estimated Completion Date:
May 31, 2026

Study Description

A total of up to 100 participants will be enrolled in this research study, at up to 15 centers. Participants in the study will receive either PUL-042 or a placebo (an inactive agent that appears identical to PUL-042). Patients will be randomized 1:1 for PUL-042 or placebo.

The first 50 patients will either be low dose PUL-042 or placebo. After review of the safety data from the initial patients, the PUL-042 dose may be increased. Subjects will be evaluated by chest x-ray and clinical status for respiratory complications.

Connect with a study center

  • City of Hope National Medical Center

    Duarte, California 91010
    United States

    Active - Recruiting

  • Northside Hospital

    Atlanta, Georgia 30342
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan 48201
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • OU Health Physicians - Infectious Disease Clinic

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • University of Texas MD Anderson MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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