Hematologic MalignanciesPhase 2NCT06665100
PUL-042 Treatment in Patients With Parainfluenza Virus (PIV), Human Metapneumovirus (hMPV) or Respiratory Syncytial Virus (RSV)
A Phase 2 study testing PUL-042 in people with Hematologic Malignancies and Hematopoietic Stem Cell Transplant (HSCT), run by Pulmotect, Inc. at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies, Hematopoietic Stem Cell Transplant (HSCT)
- What is being tested?
- PUL-042
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- 27 Jun 2025to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
Who cannot join
- Subjects will be excluded if they fulfill any of the following exclusion criteria:
- 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.
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- 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.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 11 recruiting
- Recruiting
Northside Hospital
Atlanta, Georgia, 30342
Gowri Satyanarayana, MD, 404-531-0044, adriane.strong@northside.com
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Maria Veronica Dioverti-Prono, MD, 410-955-8964, mdiover1@jhmi.edu
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Sophia Koo, MD, 617-732-8881, SKOO@bwh.harvard.edu
- Recruiting
Lineberger Cancer
Chapel Hill, North Carolina, 27514
Paul Armistead, MD, PhD, (919) 843-6847, paul_armistead@med.unc.edu
- Recruiting
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Joseph Uberti, MD, PhD, 800-527-6266, ubertij@karmanos.org
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010
Sanjeet Dadwal, MD, (855) 952-3335, sdadwal@coh.org
- Recruiting
John Theurer Cancer Center
Hackensack, New Jersey, 07601
Michele Donato, MD, 551-996-8297, michele.donato@hmhn.org
- Recruiting
University of Texas MD Anderson MD Anderson Cancer Center
Houston, Texas, 77030
Amy Spallone, MD, 713 792 2121, aspallone@mdanderson.org
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Jo-Anne Young, MD, 612-624-9996, anbu004@umn.edu
- Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
OU Health Physicians - Infectious Disease Clinic
Oklahoma City, Oklahoma, 73104
Joseph Sassine, MD, (405) 271-6434, joseph-sassine@ouhsc.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Michael Boeckh, MD, PhD, 206-667-4411, mboeckh@fredhutch.org
About this study
Official title: 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
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.
Read the detailed 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.
- Being tested
- PUL-042, Placebo
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PUL-042Drug
Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution
PlaceboDrug
Sterile Saline for Inhalation
| Study group | Role | What they receive |
|---|---|---|
| PUL-042 | Experimental | PUL-042 Inhalation Solution Receives: Drug: PUL-042 |
| Sterile Saline for Inhalation | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (14)
Change from Pre-Treatment through 28 days
To determine the difference in the change from pre-treatment to peak post-treatment RSI score through 28 days. 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.
Measured: 28 days
Proportion of Subjects Positive for Each Virus at Each Sampling Timepoint
To determine the effect of PUL-042 through 28 days for the proportion of subjects positive for each virus at each sampling timepoint.
Measured: 28 days
Change in Viral RNA Shedding Relative to Baseline (copies/mL)
To determine the effect of PUL-042 through 28 days for the change in viral RNA shedding relative to baseline (copies/mL).
Measured: 28 days
Post-Treatment Viral RNA Titers (copies/mL)
To determine the effect of PUL-042 through 28 days for post-treatment viral RNA titers (copies/mL).
Measured: 28 days
Mortality (Incidence)
To determine the effect of PUL-042 through 28 days for mortality (incidence).
Measured: 28 days
Oxygenation Requirements (Days)
The effect of PUL-042 through 28 days on the number of days on supplemental oxygen for each subject.
Measured: 28 days
Duration of ICU Care (Days)
To determine the effect of PUL-042 through 28 days for the duration of ICU care (days).
Measured: 28 days
Incidence of ICU Admission
To determine the effect of PUL-042 through 28 days for the incidence of ICU admission.
Measured: 28 days
Duration of hospitalization (Days)
To determine the effect of PUL-042 through 28 days for the duration of hospitalization (days).
Measured: 28 days
Incidence of Hospitalization
To determine the effect of PUL-042 through 28 days for the incidence of hospitalization.
Measured: 28 days
Respiratory Symptom Scores
To determine the effect of PUL-042 through 28 days for respiratory symptom scores (Patient reported symptoms of cough, shortness of breath, respiratory symptoms [cough + shortness of breath], sputum production and chest pain will each be recorded on a scale of 0 to 3 [0=absent,1= mild, 2= moderate 3= severe]).
Measured: 28 days
Incidence of Pneumonia (Clinical Diagnosis)
To determine the effect of PUL-042 through 28 days (clinical diagnosis).
Measured: 28 days
Adverse Events
To evaluate the incidence and severity of treatment emergent adverse events.
Measured: 28 days
Dose/Response
The efficacy of the 50mcg and 70mcg dose levels relative to placebo on peak RSI and change from baseline in RSI will be calculated and statistical analysis of any difference performed. 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start27 Jun 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pulmotect, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Colin Broom, MD, Principal investigator, Pulmotect, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665100
- Sponsor's protocol ID
- PUL-042-207
- Other IDs
- CP120014
- Status last verified
- Apr 2026
- First submitted
- 3 Oct 2024
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06665100
- Acronym / sponsor ID
- PUL-042-207
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pulmotect, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PUL-042 | Experimental | Drug: PUL-042PUL-042 Inhalation Solution |
| Sterile Saline for Inhalation | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (14 listed)
- Subjects will be excluded if they fulfill any of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PUL-042Pam2 : ODN (PUL-042) PUL-042 Inhalation Solution | Drug | PUL-042 |
| PlaceboSterile Saline for Inhalation | Drug | Sterile Saline for Inhalation |
Primary outcome
Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC)
Time frame: 28 days
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.
14 secondary outcomes
Change from Pre-Treatment through 28 days
Time frame: 28 days
Proportion of Subjects Positive for Each Virus at Each Sampling Timepoint
Time frame: 28 days
Change in Viral RNA Shedding Relative to Baseline (copies/mL)
Time frame: 28 days
Post-Treatment Viral RNA Titers (copies/mL)
Time frame: 28 days
Mortality (Incidence)
Time frame: 28 days
Oxygenation Requirements (Days)
Time frame: 28 days
Duration of ICU Care (Days)
Time frame: 28 days
Incidence of ICU Admission
Time frame: 28 days
Duration of hospitalization (Days)
Time frame: 28 days
Incidence of Hospitalization
Time frame: 28 days
Respiratory Symptom Scores
Time frame: 28 days
Incidence of Pneumonia (Clinical Diagnosis)
Time frame: 28 days
Adverse Events
Time frame: 28 days
Dose/Response
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Colin Broom, MD principal investigator
Pulmotect, Inc.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PUL-042 in people with Hematologic Malignancies and Hematopoietic Stem Cell Transplant (HSCT), run by Pulmotect, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colin Broom, MD (484 354 0615, cbroom@pulmotect.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of PUL-042 Inhalation Solution on Lower Respiratory Tract Complications (LRTC) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.