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

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Hematopoietic Malignancies Hodgkin Lymphoma Leukemia Lymphoma Multiple Myeloma Myelodysplastic Syndromes (MDS) Non-Hodgkin Lymphoma Plasma cell neoplasm	NCT ID:	NCT06665100
Trial Phases:	Phase II	Protocol IDs:	PUL-042-207 (primary) NCI-2024-09412 CP120014
Eligibility:	18 Years and older, Male and Female	Study Type:	Prevention
Study Sponsor:	Pulmotect, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT06665100

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.

Objectives

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.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523

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