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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

February 25, 2025

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
E Coli InfectionsAllogenic Transplant Patients
Interventions
BIOLOGICAL

SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

SNIPR001 is a live biotherapeutic product

OTHER

Placebo 10 mL

Placebo 10 mL matching to SNIPR001 will be administered.

Trial Locations (8)

10065

RECRUITING

Weill Cornell Medicine, New York

21218

RECRUITING

John Hopkins University, Baltimore

55455

RECRUITING

University of Minnesota, Minneapolis

77030

RECRUITING

University of Texas MD Anderson Cancer Center, Houston

91010

RECRUITING

City of Hope, Duarte

94118

RECRUITING

University of California, San Francisco, San Francisco

98109

RECRUITING

Fred Hutchinson Cancer Center, Seattle

15213-2582

RECRUITING

UPMC, Pittsburgh

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

Department of Health and Social Care (DHSC), UK

UNKNOWN

collaborator

Biomedical Advanced Research and Development Authority

FED

collaborator

Wellcome Trust

OTHER

collaborator

German Federal Ministry of Education and Research

OTHER_GOV

lead

SNIPR Biome Aps.

INDUSTRY