A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients

Withdrawn before enrolling · Phase 1

Conditions studied: Hematologic Diseases, Stem Cell Transplants

In brief

Subjects with hematologic malignancies or recipients of a first allogenic or autologus hematopoietic stem cell transplant, without any evidence or respiratory infection, will receive 4 doses of PUL-042 Inhalation Solution over a 2 week period. Subjects will be evaluated for tolerability of the drug. If tolerated, dose escalation may occur with up to 4 dose levels tested

Key facts

Study ID

NCT03097796

Run by

Pulmotect, Inc.

People needed

0

Starts

2024-12-01

Expected to finish

2026-05-01

Last updated by the study team

2023-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with hematologic malignancies or recipients of a first allogeneic or autologous hematopoietic stem cell transplantation and presently clinically stable
• Pulse oximetry of hemoglobin saturation ≥92% on room air
• Adult (≥18 years)
• Spirometry (FEV1 and forced vital capacity [FVC]) ≥80% of predicted value
• 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
• 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
• If male, must be surgically sterile or willing to practice two effective methods of birth control
• Ability to understand and give informed consent

You may not qualify if…

• Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI)
• Known history of chronic pulmonary disease
• Subjects who are being treated for fungal, viral, or bacterial pneumonia
• Exposure to any investigational agent (defined as any agent not approved by the Food and Drug Administration [FDA]) within 30 days prior to the Screening Visit
• Patients with a relapsed and/or refractory underlying hematologic malignancy
• HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation
• HSCT recipients with active and/or chronic graft versus host disease
• Patients on systemic corticosteroids (oral or intravenous)
• Absolute neutrophil count (ANC) < 1,000 cells/mL
• Clinically significant bacteremia or fungemia
• Current smokers or subjects with any history of smoking

Where it is running

• University of Texas MD Anderson MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.