PUL-042 for Blood Cancers

Recruiting in Palo Alto (17 mi)

Overseen byColin Broom, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Pulmotect, Inc.

Prior Safety Data

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.

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.

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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.

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Treatment Details

Interventions

PUL-042 (Virus Therapy)

Trial OverviewThe 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

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PUL-042Experimental Treatment1 Intervention

PUL-042 Inhalation Solution

Group II: Sterile Saline for InhalationPlacebo Group1 Intervention

Placebo