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 PreTransplant

Launched by SNIPR BIOME APS. · Apr 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SNIPR001 to see if it is safe and how well it works for patients with certain blood cancers, especially those who are preparing for a stem cell transplant. The trial will also look at how the body absorbs the drug and how well it can help prevent infections caused by a specific type of bacteria known as E. coli. Participants will take SNIPR001 along with another antibiotic called levofloxacin.

To be eligible for this study, participants must be at least 18 years old, have a confirmed blood cancer diagnosis, and be scheduled for a stem cell transplant. They must also have a specific type of E. coli in their system and agree to follow the study's procedures, including taking the medications and attending regular check-ups. Throughout the trial, participants will be monitored for safety and how their bodies respond to the treatment. It’s important to know that some people may not be able to join the study, especially if they are currently taking certain medications or have specific allergies.

Gender

ALL

Eligibility criteria

• 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 Day -2, 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.