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

NCT03097796 | Withdrawn Phase 1 DMC FDA Drug

• 2 other identifiers: PUL-042-201AR44HL127677
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hematologic Diseases; Stem Cell Transplants

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in one Second (FEV1)

  Evaluation of increasing doses of PUL-042 Inhalation Solution on FEV1

  3 weeks

Secondary Outcomes (1)

• Serum proteomics

  3 weeks

Study Arms (1)

PUL-042

EXPERIMENTAL

PUL-042 Inhalation Solution

Drug: PUL-042

Interventions

PUL-042 DRUG

PUL-042 Inhalation Solution

PUL-042

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pulmotect, Inc.: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

University of Texas MD Anderson MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Pam2CSK4 acetate and ODN M362 combination

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

• Roy F Chemaly, MD, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)