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
NCT ID: NCT06938867
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2025-02-25
2026-04-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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SNIPR001 Active
12 patients on SNIPR001 (BID for up to 30 days)
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
SNIPR001 is a live biotherapeutic product
Placebo
12 patients on Placebo (BID for up to 30 days)
Placebo 10 mL
Placebo 10 mL matching to SNIPR001 will be administered.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Bill and Melinda Gates Foundation
OTHER
Department of Health and Social Care (DHSC), UK
UNKNOWN
Biomedical Advanced Research and Development Authority
FED
Wellcome Trust
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
SNIPR Biome Aps.
INDUSTRY
Responsible Party
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Locations
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City of Hope
Duarte, California, United States
University of California, San Francisco
San Francisco, California, United States
John Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Weill Cornell Medicine
New York, New York, United States
UPMC
Pittsburgh, Pennsylvania, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Countries
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Facility Contacts
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Other Identifiers
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SNIPR001-002
Identifier Type: -
Identifier Source: org_study_id
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