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

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: E Coli Infections, Allogenic Transplant Patients

In brief

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.

Key facts

Study ID

NCT06938867

Run by

SNIPR Biome Aps.

People needed

24

Starts

2025-02-25

Expected to finish

2026-04-01

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• University of California, San Francisco — San Francisco, California, United States (enrolling)
• John Hopkins University — Baltimore, Maryland, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Weill Cornell Medicine — New York, New York, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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