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

Conditions

• Allogenic Transplant Patients
• E Coli Infections

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli — BIOLOGICAL
  SNIPR001 is a live biotherapeutic product
• Placebo 10 mL — OTHER
  Placebo 10 mL matching to SNIPR001 will be administered.

Study Details

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.

Key Dates

Start date

Feb 25, 2025

Status verified

Oct 2025

Primary completion

Apr 1, 2026

Completion

Apr 1, 2026

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: SNIPR001 Active
  12 patients on SNIPR001 (BID for up to 30 days)
• Placebo Comparator: Placebo
  12 patients on Placebo (BID for up to 30 days)

Primary Outcome Measure

To assess the safety and tolerability of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with standard of care (SoC) levofloxacin prophylaxis [ Time Frame: Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8 ]

Locations (8)

Find similar trials in Duarte, CA