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

NCT06665100 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: PUL-042-207CP120014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Hematologic Malignancies; Hematopoietic Stem Cell Transplant (HSCT)

Outcome Measures

Primary Outcomes (1)

• Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC)

  Determine efficacy of PUL-042 Inhalation Solution on lower respiratory tract complications (LRTC) using the peak post-treatment radiologic severity index (RSI) score in subjects with hematologic malignancies (HM \[lymphoma, multiple myeloma and leukemia\]) and hematopoietic stem cell transplant (HSCT) recipients with documented parainfluenza virus (PIV), human metapneumovirus (hMPV), or respiratory syncytial virus (RSV) infection. The RSI is a quantitative score based on the presence of pulmonary infiltrates in three zones in both lungs, a total of six zones. Normal in all zones would be a score of zero with a maximum score of 72, which represents total consolidation in all six zones.

  28 days

Secondary Outcomes (14)

• Change from Pre-Treatment through 28 days

  28 days

• Proportion of Subjects Positive for Each Virus at Each Sampling Timepoint

  28 days

• Change in Viral RNA Shedding Relative to Baseline (copies/mL)

  28 days

• Post-Treatment Viral RNA Titers (copies/mL)

  28 days

• Mortality (Incidence)

  28 days

Study Arms (2)

PUL-042

EXPERIMENTAL

PUL-042 Inhalation Solution

Drug: PUL-042

Sterile Saline for Inhalation

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PUL-042 DRUG

Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution

PUL-042

Placebo DRUG

Sterile Saline for Inhalation

Sterile Saline for Inhalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with hematologic malignancies (i.e., leukemia, lymphoma, or multiple myeloma) or recipients of an allogeneic or autologous hematopoietic stem cell transplantation for one of the following diagnoses: leukemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, and myelodysplastic and myeloproliferative disorder.
• Subjects who have undergone active cytotoxic chemotherapy within 6 months or subjects who are on an immunosuppressive therapy (e.g., alemtuzumab, ibrutinib, mycophenolate mofetil, corticosteroids ≥1mg/kg prednisone equivalent).
• 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.
• Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure.
• Subjects must be symptomatic with upper or lower respiratory tract symptoms such as rhinorrhea, sore throat or cough and must be dosed within 6 days from the onset of symptoms.
• Chest X-ray with a Radiologic Severity Index (RSI) score of 6 or lower.
• Subjects must have pulse oximetry of hemoglobin saturation ≥ 93% on room air.
• Spirometry (forced expiratory volume in one second \[FEV1\] and forced vital capacity \[FVC\]) ≥70% of predicted value.
• Adult (≥ 18 years of age).
• If female, must be either post-menopausal (one year or greater without menses), surgically sterile, or, for female subjects of child-bearing potential who are capable of conception must be: practicing two effective methods of birth control (acceptable methods include intrauterine device, spermicide, barrier, male partner surgical sterilization, and hormonal contraception) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
• If female, must not be pregnant, plan to become pregnant, or nurse a child during the study and through 30 days after completion of the study. A pregnancy test must be negative at the Screening Visit, prior to dosing on Day 1.
• If male, must be surgically sterile or willing to practice two effective methods of birth control (acceptable methods include barrier, spermicide, or female partner surgical sterilization) during the study and through 30 days after completion of the study. Abstinence is not classified as an effective method of birth control.
• Ability to understand and give informed consent.

You may not qualify if:

• Patients with a pulse oximetry of hemoglobin saturation less than 93% on room air.
• Known history of chronic pulmonary disease (e.g., asthma \[including atopic asthma, exercise-induced asthma, or asthma triggered by respiratory infection\], chronic pulmonary disease, pulmonary fibrosis, COPD), pulmonary hypertension, or heart failure.
• Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days.
• Exposure to any investigational agent (defined as any non-FDA-approved agent) within 30 days, or 5 half-lives of the investigational agent, whichever is longer, prior to the Screening Visit.
• Allogeneic HSCT recipients with an ISI of 3 or less.
• Autologous HSCT recipients more than 3 months after the transplant procedure.
• Patients with a relapsed and/or refractory underlying hematologic malignancy with a life expectancy of less than 2 months.
• HSCT recipients in the pre-engraftment period.
• Chest X-ray with an RSI of \>6.
• Patients documented to be positive for other respiratory viruses (limited to influenza, SARS-CoV-2, adenovirus, or coronavirus) within 7 days prior to the Screening Visit, as determined by local testing (additional screening testing is not required).
• Clinically significant bacteremia or fungemia within 7 days prior to the Screening Visit that has not been adequately treated, as determined by the Principal Investigator.
• Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.
• Previous exposure to PUL-042 Inhalation Solution.

Sponsors & Collaborators

• Pulmotect, Inc.: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (11)

City of Hope National Medical Center

Duarte, California, 91010, United States

RECRUITING

Northside Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

John Theurer Cancer Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Lineberger Cancer

Chapel Hill, North Carolina, 27514, United States

RECRUITING

OU Health Physicians - Infectious Disease Clinic

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

University of Texas MD Anderson MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Pam2CSK4 acetate and ODN M362 combination

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Colin Broom, MD

  Pulmotect, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Colin Broom, MD

CONTACT

484 354 0615; cbroom@pulmotect.com

Brenton Scott, Ph D

CONTACT

713 579 9226; bscott@pulmotect.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 30, 2024
• Study Start: June 27, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)