PUL-042 for Blood Cancers

Recruiting at 10 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new inhalation solution called PUL-042 to determine its effectiveness in reducing lung infections in individuals with blood cancers or those who have undergone stem cell transplants. Participants will receive either the PUL-042 treatment or a placebo to assess its efficacy. The trial seeks individuals with symptoms like a sore throat or cough who have tested positive for specific viruses. It is suitable for those who have recently undergone chemotherapy or stem cell transplants and are experiencing respiratory symptoms. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

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.

Is there any evidence suggesting that PUL-042 is likely to be safe for humans?

Research shows that PUL-042 has been tested for safety in people with blood cancers. In earlier studies, patients received increasing doses of PUL-042 to assess tolerance. Results indicated that most people did not experience serious side effects, suggesting it was generally well-tolerated.

As with any treatment, side effects may occur, but they are usually mild. In previous studies, patients underwent chest x-rays and other health checks to ensure their well-being. If they tolerated the treatment, the dose was sometimes increased.

PUL-042 is now in a Phase 2 study, indicating that earlier research demonstrated sufficient safety to proceed. This phase focuses more on the treatment's effectiveness while still monitoring safety. Overall, PUL-042 appears to have a good safety record based on current evidence. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for blood cancers?

PUL-042 is unique because it offers a new approach to treating blood cancers by using an inhalation solution, which is quite different from the traditional chemotherapy or targeted therapy options that are typically administered intravenously or orally. Researchers are excited about PUL-042 because it represents a novel mechanism of action, potentially enhancing the body's innate immune response to fight cancer cells more effectively. This inhalation method could also mean fewer systemic side effects, as it targets the lungs directly, offering a promising alternative to current treatment methods.

What evidence suggests that PUL-042 might be an effective treatment for lung infections in blood cancer patients?

Studies have shown that PUL-042, which participants in this trial may receive, might help reduce lung infections in people with blood cancers. This treatment strengthens the body's defense against viruses. Earlier research demonstrated PUL-042's promise in aiding patients with blood-related conditions. For those with viral infections like RSV, it could lessen symptom severity. Although more research is needed, early findings suggest that PUL-042 could benefit these patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Colin Broom, MD

Principal Investigator

Pulmotect, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03097796

A Multiple Ascending Dose Study of PUL-042 in Stem Cell ... This is an open-label multiple ascending dose study with a 3+3 study design to examine the safety and tolerability of PUL-042 Inhalation Solution in subjects ...

2. withpower.com withpower.com/trial/phase-2-hematologic-neoplasms-9-2025-c4dba

PUL-042 for Blood Cancers 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7724912/

a report from the ASH Research Collaborative Data Hub - PMC Patients with cancer, and especially those with hematologic malignancies, may be at especially high risk of adverse outcomes, including ...

4. nature.com nature.com/articles/s41392-023-01521-5

Immunotherapy in hematologic malignancies Alemtuzumab combined with CHOP similarly showed better outcomes with an ORR of 72% and CRR of 60% in the phase 3 trial. In recent years, mAbs ...

5. ashpublications.org ashpublications.org/blood/article/123/15/2293/32245/Advances-in-the-treatment-of-hematologic

Advances in the treatment of hematologic malignancies using ... A phase 1/2 study of INO combined with rituximab showed impressive ORRs of 87%, 74%, and 20% for relapsed FL, relapsed DLBCL, and refractory ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03097796

A Multiple Ascending Dose Study of PUL-042 in Stem Cell ... This is an open-label multiple ascending dose study with a 3+3 study design to examine the safety and tolerability of PUL-042 Inhalation Solution in subjects ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06665100

Study Details | NCT06665100 | PUL-042 Treatment in ... 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 ...

8. mdanderson.org mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2024-1050.html

A phase 2 multiple dose study to evaluate the efficacy and ... 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. Resources and Links.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3983610/

Advances in the treatment of hematologic malignancies ... Monoclonal antibody therapy has revolutionized cancer treatment by significantly improving patient survival both in solid tumors and hematologic malignancies.