Clinical study
NCT06938867
| Status | Recruiting |
|---|---|
| Type | Trial |
| Countries | United States |
| Conditions studied | E Coli Infections; Allogenic Transplant Patients |
| Study years | Completed 2027 (estimated); start date disputed |
| Entry review | 2026-11-03 |
Participation
Check the study record or contact the study team for current recruitment and eligibility.
Study eligibility
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 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 description
Official study 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
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. The study consists of two parts. Part 1 will include 24 randomized and dosed patients. Part 2 will be added with amendment 3 and will include 42 randomized and dosed patients. Thus, approximately 66 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.
Study registrations
| ClinicalTrials.gov | NCT06938867 |
|---|
Recorded study locations (10)
Locations listed in the study record; this does not confirm current recruitment or treatment outside the study. A site label may be older than the overall study status.
City of Hope
Duarte, California, United States
Recorded site status: Recruiting. Study location source ↗
University of California, San Francisco
San Francisco, California, United States
Recorded site status: Recruiting. Study location source ↗
Johns Hopkins University
Baltimore, Maryland, United States
Recorded site status: Recruiting. Study location source ↗
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recorded site status: Not yet recruiting. Study location source ↗
University of Minnesota
Minneapolis, Minnesota, United States
Recorded site status: Recruiting. Study location source ↗
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Recorded site status: Not yet recruiting. Study location source ↗
Weill Cornell Medicine
New York, New York, United States
Recorded site status: Recruiting. Study location source ↗
UPMC
Pittsburgh, Pennsylvania, United States
Recorded site status: Recruiting. Study location source ↗
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recorded site status: Recruiting. Study location source ↗
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Recorded site status: Recruiting. Study location source ↗
Related programs(1)
SNIPR Biome
Provider-listed inquiry route
Recorded program–study link. Website
Notes from the source review
- Registry updated October 8, 2026: Part 1 completed and Part 2 initiated; estimated enrollment 66; estimated completion October 2027. Eight listed sites recruiting; Dana-Farber and Memorial Sloan Kettering not yet recruiting. Study-specific eligibility applies.
Sources and updates
Entry reviewed . This is the date of our source review, not a confirmation of availability today.
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| Study ID | nct06938867 |
|---|