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NCT06938867 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of E Coli Infections and Allogenic Transplant Patients, sponsored by SNIPR Biome Aps..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 8
- Study locations
NCT06938867: Recruiting Phase 1 study of E Coli Infections and Allogenic Transplant Patients, sponsored by SNIPR Biome Aps..
NCT06938867 is a Phase 1 study of E Coli Infections and Allogenic Transplant Patients that is actively recruiting participants, run by SNIPR Biome Aps.. The registered enrollment target is 24 participants, below the 1,191-participant average among 4 other E Coli Infections trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06938867, a Phase 1 study of E Coli Infections and Allogenic Transplant Patients, is actively recruiting participants, sponsored by SNIPR Biome Aps..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 8
- Study locations
Study Summary
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.
Primary Outcome
1. Incidence and severity of adverse events (AEs), treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs), based on National Cancer Institute Common Terminology Criteria for Adverse Events Version 5 (NCI CTCAE v5.0). AEs involving graft versus host disease (GvHD) will be graded according to the International Bone Marrow Registry Severity Index. 2. Time to neutrophil recovery (defined as the 1st day of ANC ≥0.5x109/L for 3 consecutive days) 3. Incidence of non-relapse mortal
Conditions Studied
Interventions
- BIOLOGICAL SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
- OTHER Placebo 10 mL
Study Locations (8)
California
- City of Hope - Duarte
- University of California, San Francisco - San Francisco
Maryland
- John Hopkins University - Baltimore
Minnesota
- University of Minnesota - Minneapolis
New York
- Weill Cornell Medicine - New York
Pennsylvania
- UPMC - Pittsburgh
Texas
- University of Texas MD Anderson Cancer Center - Houston
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2025-02-25 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
What NCT06938867 shows while recruiting
NCT06938867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,191-participant average among 4 other E Coli Infections trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with E Coli Infections appearing as the primary indexed condition, and to 2 interventions - of which SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli is the first listed.
NCT06938867 lists 8 locations in 7 states (California, Maryland, Minnesota).
Frequently Asked Questions
What is clinical trial NCT06938867 about?
NCT06938867 is a clinical study titled "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.
What is the current status of trial NCT06938867?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2025-02-25. Estimated completion is 2026-04-01.
What conditions does trial NCT06938867 study?
This clinical trial studies the following conditions: E Coli Infections, Allogenic Transplant Patients.
What interventions are being tested in trial NCT06938867?
The interventions under investigation include: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli (BIOLOGICAL), Placebo 10 mL (OTHER).
Who is sponsoring clinical trial NCT06938867?
This trial is sponsored by SNIPR Biome Aps., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06938867 being conducted?
This trial has 8 study locations across California, Maryland, Minnesota, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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