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Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant
Sponsor: SNIPR Biome Aps.
Summary
This is a Phase 1b/2a study in allogenic hematopoietic stem cell transplant patients to investigate the safety, PK, PD and preliminary efficacy of multiple oral administrations of SNIPR001 when given concomitantly with SoC levofloxacin. The study consists of two parts. Part 1 will include 24 randomized and dosed patients. Part 2 will be added with amendment 3 and will include 42 randomized and dosed patients. Thus, approximately 66 patients will be randomized 1:1 to oral dosing of SNIPR001 or matching placebo, to be taken concomitantly with SoC levofloxacin prophylaxis. Subjects will be followed until 100 days post allo-HSCT transplant.
Official title: A Phase 1b/2a, Randomized, Double-blind Study to Investigate Safety, Tolerability, PK, PD, and Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplantation Receiving Fluoroquinolone Prophylaxis and Harboring Fluoroquinolone-Resistant Escherichia Coli Pre-Transplant
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2024-12-04
Completion Date
2027-10
Last Updated
2026-10-08
Healthy Volunteers
No
Interventions
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
SNIPR001 is a live biotherapeutic product
Placebo 10 mL
Placebo 10 mL matching to SNIPR001 will be administered.
Locations (10)
City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States