PUL-042 for Blood Cancers

Recruiting at 7 trial locations

Overseen By Brenton Scott, Ph D

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Pulmotect, Inc.

Disqualifiers: Chronic pulmonary disease, Heart failure, Others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 week

100 Participants Needed

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have been treated for pneumonia in the last 30 days or have taken any investigational drugs recently. It's best to discuss your specific medications with the trial team.

Research Team

Colin Broom, MD

Principal Investigator

Pulmotect, Inc.

Eligibility Criteria

This trial is for patients with blood cancers or who have had a bone marrow transplant and are now suffering from lung infections caused by specific viruses (PIV, hMPV, or RSV). Participants should be diagnosed with these viral infections to qualify.

Inclusion Criteria

Subjects with a nasopharyngeal swab positive for PIV, RSV, or hMPV by molecular assay

I understand the study and can give my consent.

I am following the required contraception guidelines.

Exclusion Criteria

Patients with pulse oximetry of hemoglobin saturation less than 93% on room air

I have a history of chronic lung or heart conditions.

I had a stem cell transplant using my own cells more than 3 months ago.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PUL-042 or placebo administered 3 times over a 6-day period

1 week

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Treatment Details

Interventions

• PUL-042

Trial Overview The study is testing PUL-042, an experimental drug, against a placebo. It's given as an inhalation solution three times over six days to see if it can lessen the severity of lung infections in the patient group described.

Participant Groups

Group I: PUL-042 Experimental Treatment 1 Intervention

PUL-042 Inhalation Solution

Group II: Sterile Saline for Inhalation Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Pulmotect, Inc.

Lead Sponsor

Trials

7

Recruited

500+

Cancer Prevention Research Institute of Texas

Collaborator

Trials

55

Recruited

98,900+