Recruiting
Phase 1
Phase 2

SNIPR001

Sponsor:

SNIPR Biome Aps.

Code:

NCT06938867

Conditions

E Coli Infections

Allogenic Transplant Patients

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

Placebo 10 mL

Study Details

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

Study ID

NCT06938867

Start date

Feb 25, 2025

Status verified date

Oct, 2025

Completion date

Apr 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: SNIPR001 Active

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

placebo comparator: Placebo

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

Interventions

SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

SNIPR001 is a live biotherapeutic product

Placebo 10 mL

Placebo 10 mL matching to SNIPR001 will be administered.

Primary outcome measure

  • 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 [ Time Frame: Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8 ]

Central Contacts and Locations

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Dr Deepa Nanayakarra

626-275-8069flewis@coh.org

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94118

Contacts

John Hopkins University

Recruiting

Baltimore, Maryland, United States, 21218

Contacts

Dr Veronica Dioverti

(410) 516-8000OCT@jh.edu

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Weill Cornell Medicine

Recruiting

New York, New York, United States, 10065

Contacts

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213-2582

Contacts

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

More Information

Sponsor

SNIPR Biome Aps.

Last update posted

Oct 14, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SNIPR Biome Aps. on 2025-10-14.