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

NCT06938867 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SNIPR001-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

E Coli Infections; Allogenic Transplant Patients

Outcome Measures

Primary Outcomes (1)

• 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

  1. 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. 2. Time to neutrophil recovery (defined as the 1st day of ANC ≥0.5x109/L for 3 consecutive days) 3. Incidence of non-relapse mortality (NRM) 4. Incidence of all-cause mortality 5. Incidence of primary graft failure and secondary graft failure 6. Incidence of acute graft versus host disease (aGvHD) 7. Incidence of Clostridioides difficile (C. difficile) diarrhea 8. 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 Outcomes (5)

• To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis

  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

  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

  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

  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

  From the first dose of randomized treatment through 30 days after transplant.

Study Arms (2)

SNIPR001 Active

ACTIVE COMPARATOR

12 patients on SNIPR001 (BID for up to 30 days)

Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

Placebo

PLACEBO COMPARATOR

12 patients on Placebo (BID for up to 30 days)

Other: Placebo 10 mL

Interventions

SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli BIOLOGICAL

SNIPR001 is a live biotherapeutic product

SNIPR001 Active

Placebo 10 mL OTHER

Placebo 10 mL matching to SNIPR001 will be administered.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age at the time of consent.
• Patient is able and willing to provide written informed consent prior to any study-related procedure.
• Confirmed diagnosis of any hematologic malignancy.
• Planned to undergo an allogeneic hematopoietic stem cell transplant.
• Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
• 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 +/-).
• 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.
• 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.
• 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.

You may not qualify if:

• 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.
• 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.
• Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer Gold treatment.
• Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
• Female patients who are pregnant or lactating.
• Have abnormal liver enzymes (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>2 × upper limit of normal \[ULN\] or total bilirubin \>1.5 × ULN).
• Have hepatic disease associated with impaired liver function.
• Have a history of Achilles tendinopathy or tendon rupture.

Sponsors & Collaborators

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

Study Sites (8)

City of Hope

Duarte, California, 91010, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94118, United States

RECRUITING

John Hopkins University

Baltimore, Maryland, 21218, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Weill Cornell Medicine

New York, New York, 10065, United States

RECRUITING

UPMC

Pittsburgh, Pennsylvania, 15213-2582, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

MeSH Terms

Conditions

Escherichia coli Infections

Condition Hierarchy (Ancestors)

Enterobacteriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: February 25, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)