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
Start Date
12/4/2024
Completion Date
10/1/2027
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.
Detailed Description
Patients scheduled for allo-HSCT will be pre-screened for the presence (in the gut) of FQR E. coli cultured from a perianal swab. Part 1 has been completed and Part 2 has been initiated.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
Placebo 10 mL
Conditions
Locations
City of Hope
Duarte, California 91010
United States
University of California, San Francisco
San Francisco, California 94118
United States
Johns Hopkins University
Baltimore, Maryland 21218
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Weill Cornell Medicine
New York, New York 10065
United States
UPMC
Pittsburgh, Pennsylvania 15213-2582
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States