Clinical trial · Interventional
A Multiple Ascending Dose Study of PUL-042 in Stem Cell Transplant Recipients
An Open-Label, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of PUL-042 Inhalation Solution in Subjects With Hematologic Malignancies and Recipients of Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Development plan revised
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Diseases | — | UNRESOLVED | — |
| Stem Cell Transplants | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PUL-042 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PUL-042
- description
- PUL-042 Inhalation Solution
- interventionNames
- Drug: PUL-042
Primary outcomes (1)
- measure
- Forced Expiratory Volume in one Second (FEV1)
- timeFrame
- 3 weeks
- description
- Evaluation of increasing doses of PUL-042 Inhalation Solution on FEV1
Secondary outcomes (1)
- measure
- Serum proteomics
- timeFrame
- 3 weeks
- description
- Evalution of increasing doses of PUL-042 Inhalation Solution on serum proteomic profile
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects with hematologic malignancies or recipients of a first allogeneic or autologous hematopoietic stem cell transplantation and presently clinically stable 2. Pulse oximetry of hemoglobin saturation ≥92% on room air 3. Adult (≥18 years) 4. Spirometry (FEV1 and forced vital capacity \[FVC\]) ≥80% of predicted value 5. 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 6. 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 7. If male, must be surgically sterile or willing to practice two effective methods of birth control 8. Ability to understand and give informed consent Exclusion Criteria: 1. Subjects with any evidence of respiratory infection including any signs or symptoms of either a lower respiratory infection (LRI) or upper respiratory infection (URI) 2. Known history of chronic pulmonary disease 3. Subjects who are being treated for fungal, viral, or bacterial pneumonia 4. 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 5. Patients with a relapsed and/or refractory underlying hematologic malignancy 6. HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation 7. HSCT recipients with active and/or chronic graft versus host disease 8. Patients on systemic corticosteroids (oral or intravenous) 9. Absolute neutrophil count (ANC) \< 1,000 cells/mL 10. Clinically significant bacteremia or fungemia 11. Current smokers or subjects with any history of smoking
References
Publications (0)
Data not yet available