RecruitingPhase 1Phase 2NCT06938867

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

Sponsor

SNIPR Biome Aps.

Enrollment

24 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

E Coli Infections Allogenic Transplant Patients

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Placebo 10 mL and a biological treatment called SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli for people with allogenic transplant patients and e coli infections. The study is currently recruiting participants at 8 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

SNIPR001 is a live biotherapeutic product

OTHERPlacebo 10 mL

Placebo 10 mL matching to SNIPR001 will be administered.

Locations(8)

City of Hope

Duarte, California, United States

University of California, San Francisco

San Francisco, California, United States

John Hopkins University

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, 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

View Full Details on ClinicalTrials.gov

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NCT06938867