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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

Efficacy and Safety of PUL-042 Inhalation Solution in Reducing Lower Respiratory Tract Complications in Patients With Hematologic Malignancies and Recipients of Hematopoietic Stem Cell Transplantation (HSCT) With Documented Viral Infections With PIV, hMPV or RSV

PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV) (NCT06665100) is a Phase 2 interventional studying Hematologic Malignancies and Hematopoietic Stem Cell Transplant (HSCT), sponsored by Pulmotect, Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Hematologic Malignancies and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Hematologic Malignancies subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) by molecular assay by a local laboratory AND subjects must fulfill the following inclusion criteria to be eligible for participation in the study: 1. 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. 2. 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). 3. Subjects who are recipients of an allogeneic hematopoietic stem cell transplant (HSCT) must be deemed high risk with an weakened immune system Scoring Index (ISI) , of greater or equal to 4. 4. Subjects who are recipients of an autologous HSCT must be within 3 months of the transplant procedure. 5. 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. 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 vital capacity \[FVC\]) ≥70% of predicted value. 9. Adult (≥ 18 years of age). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Subjects will be eligible for entry into the study if a nasopharyngeal swab is positive for PIV, RSV, or hMPV (as a single pathogen or a mixed infection with rhinovirus) by molecular assay by a local laboratory AND subjects must fulfill the following inclusion criteria to be eligible for participation in the study: 1. 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. 2. 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). 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 of the transplant procedure. 5. 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. 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 vital capacity \[FVC\]) ≥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 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. 11. 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. 12. 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. 13. Ability to understand and give informed consent. 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 room air. 2. 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. 3. Subjects treated for fungal, viral, or bacterial pneumonia in the previous 30 days. 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 is longer, 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 malignancy with 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 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). 11. 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. 12. 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. 13. Previous exposure to PUL-042 Inhalation Solution.

Treatments Being Tested

DRUG

PUL-042

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

DRUG

Placebo

Sterile Saline for Inhalation

Locations (11)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

City of Hope National Medical Center
Duarte, California, United States
Northside Hospital
Atlanta, Georgia, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Lineberger Cancer
Chapel Hill, North Carolina, United States
OU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, United States
University of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06665100), the sponsor (Pulmotect, Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06665100 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06665100?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06665100?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06665100. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06665100. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.