NCT06938867

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: SNIPR Biome Aps. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. Approximately 24 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.

Conditions

• E Coli Infections
• Allogenic Transplant Patients

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-25
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2025-04-22
• Last updated: 2025-10-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study