Actively Recruiting
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
Led by SNIPR Biome Aps. · Updated on 2025-10-14
24
Participants Needed
8
Research Sites
57 weeks
Total Duration
On this page
Sponsors
S
SNIPR Biome Aps.
Lead Sponsor
B
Bill and Melinda Gates Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female 18 years of age or older at the time of consent
- Able and willing to provide written informed consent before any study procedures
- Confirmed diagnosis of any hematologic malignancy
- Planned to undergo an allogeneic hematopoietic stem cell transplant
- Scheduled to receive fluoroquinolone (levofloxacin) prophylaxis
- Colonized with fluoroquinolone-resistant E. coli confirmed by perianal swab
- Female patients must be non-childbearing (surgically sterile or menopausal for at least 1 year) or agree to use effective contraception during treatment and for 28 days after last dose
- Male patients must use highly effective contraception during dosing and for 28 days after last dose
- Female patients of childbearing potential must have negative pregnancy tests at screening and on Day -2 before dosing
- Willing to comply with all scheduled visits, tests, and study procedures including taking study medications
You will not qualify if you...
- Use of treatments that may interact with study drug within 14 days before first dose
- Use or planned use of antibiotics active against E. coli (except TMP-SMX and levofloxacin) between pre-screening and end of treatment
- Known allergy to any component of SNIPR001, levofloxacin, or Alka-Seltzer Gold
- Unwilling or unable to comply with protocol requirements, including providing stool samples
- Pregnant or breastfeeding female patients
- Abnormal liver enzyme levels (ALT or AST >2 times upper limit of normal, or total bilirubin >1.5 times upper limit)
- Liver disease causing impaired liver function
- History of Achilles tendinopathy or tendon rupture
AI-Screening
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Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of California, San Francisco
San Francisco, California, United States, 94118
Actively Recruiting
3
John Hopkins University
Baltimore, Maryland, United States, 21218
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
Weill Cornell Medicine
New York, New York, United States, 10065
Actively Recruiting
6
UPMC
Pittsburgh, Pennsylvania, United States, 15213-2582
Actively Recruiting
7
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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