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

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.

Study Overview

• Status: Recruiting
• Conditions: E Coli Infections; Allogenic Transplant Patients
• Intervention / Treatment: Other: Placebo 10 mL; Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Alice Troy; Phone Number: +45 31 67 70 76; Email: at@sniprbiome.com

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • Recruiting
      • City of Hope
      • Contact: Dr Deepa Nanayakarra; Phone Number: 626-275-8069; Email: flewis@coh.org
    • San Francisco, California, United States, 94118
      • Recruiting
      • University of California, San Francisco
      • Contact: Dr Sarah Doernberg; Phone Number: (415) 476-1000; Email: airway@ucsf.edu
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Recruiting
      • John Hopkins University
      • Contact: Dr Veronica Dioverti; Phone Number: (410) 516-8000; Email: OCT@jh.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Contact: Dr Jo-Anne Young; Phone Number: 612-626-3500; Email: sfinder@umn.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Dr Michael Satlin; Phone Number: 646-962-8215; Email: jctosrc@med.cornell.edu
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • Recruiting
      • UPMC
      • Contact: Dr Will Garner; Phone Number: (412) 648-6377; Email: snookse@upmc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas MD Anderson Cancer Center
      • Contact: Dr. George Chen; Phone Number: (877) 632-6789; Email: jrbigcal@mdanderson.org
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center
      • Contact: Dr Catherine Liu; Phone Number: 855-557-0555; Email: catherine.liu@fredhutch.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female ≥18 years of age at the time of consent.
2. Patient is able and willing to provide written informed consent prior to any study-related procedure.
3. Confirmed diagnosis of any hematologic malignancy.
4. Planned to undergo an allogeneic hematopoietic stem cell transplant.
5. Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
6. Colonized with Fluoroquinolone resistant E. coli (patients will be pre-screened for the presence of at least 1 Fluoroquinolone resistant E. coli colony [cultured from a perianal swab] performed at the local hospital lab, qualitative assessment +/-).
7. Female patients must be of non-childbearing potential (surgically sterile or menopausal for at least 1 year) or agree to use a highly effective contraception method, per local standard, while receiving treatment with SNIPR001 and for 28 days after the last dose of SNIPR001. Male patients must utilize highly effective contraceptive precautions for the duration of SNIPR001 dosing and for 28 days after the last dose of SNIPR001.
8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative serum or urine test on Day -2 prior to SNIPR001 dosing.
9. Are willing to comply with all scheduled visits, laboratory tests, and other study procedures, including drinking the study medications, in the opinion of the Investigator.

Exclusion Criteria:

1. Use of any treatment (approved or investigational product) considered to interact with the study drug, or which might impact the outcome of the study within 14 days (or 5 half-lives of the approved or investigational product, whichever is greater) prior to the first administration of study drug, as judged by the Investigator.
2. Use or planned use of any antibiotics with intrinsic activity against E. coli in the gut (e.g., beta-lactam antibiotics) between Pre-Screening and until the end of the SNIPR001/placebo treatment period, with the exception of TMP-SMX and levofloxacin.
3. Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
4. Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
5. Female patients who are pregnant or lactating.
6. Have abnormal liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 × upper limit of normal [ULN] or total bilirubin >1.5 × ULN).
7. Have hepatic disease associated with impaired liver function.
8. Have a history of Achilles tendinopathy or tendon rupture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: SNIPR001 Active; 12 patients on SNIPR001 (BID for up to 30 days)	Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli; SNIPR001 is a live biotherapeutic product
Placebo Comparator: Placebo; 12 patients on Placebo (BID for up to 30 days)	Other: Placebo 10 mL; Placebo 10 mL matching to SNIPR001 will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the safety and tolerability of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with standard of care (SoC) levofloxacin prophylaxis	Incidence and severity of adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE v5.0). AEs involving graft versus host disease (GvHD) will be graded according to the International Bone Marrow Registry Severity Index.; Time to neutrophil recovery (defined as the 1st day of ANC ≥0.5x109/L for 3 consecutive days); Incidence of non-relapse mortality (NRM); Incidence of all-cause mortality; Incidence of primary graft failure and secondary graft failure; Incidence of acute graft versus host disease (aGvHD); Incidence of Clostridioides difficile (C. difficile) diarrhea; Median number of days from transplant to onset of neutropenic fever	Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis	Proportion of patients with an increase in E. coli relative abundance in stool	Baseline and last day of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis	Change in E. coli relative abundance in stool	Day-2 to end of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis	Change in E. coli absolute abundance	Day-2 to end of dosing
To assess the pharmacokinetics (PK) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis	Recovery of SNIPR001 from first dose of randomized treatment through 7 days after last dose randomized treatment in stool, blood and urine based on the number of plaque-forming units (PFUs) per gram in stool, and the number of PFUs per milliliter in blood and urine.	From first dose of randomized treatment through 7 days after last dose of randomized treatment in stool, blood and urine
To assess the preliminary efficacy of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis	Proportion of patients with E. coli bloodstream infections (BSIs) assessed from the first dose of randomized treatment through 30 days after transplant.; Proportion of patients with gram-negative BSIs only, assessed from first dose of randomized treatment through 30 days after transplant.; Proportion of patients with gram-positive BSIs only, assessed from first dose of randomized treatment through 30 days after transplant.; Total BSIs assessed from first dose of randomized treatment through 30 days after transplant.; Incidence and number of neutropenic fever episodes from first dose of randomized treatment through 30 days after transplant.; Incidence and number of patients receiving broad-spectrum antibiotics on suspicion of a bloodstream infection	From the first dose of randomized treatment through 30 days after transplant.

Collaborators and Investigators

• Sponsor: SNIPR Biome Aps.
• Collaborators: German Federal Ministry of Education and Research; Bill and Melinda Gates Foundation; Wellcome Trust; Biomedical Advanced Research and Development Authority; Department of Health and Social Care (DHSC), UK

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 21, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Enterobacteriaceae Infections; Escherichia coli Infections
• Other Study ID Numbers: SNIPR001-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No