Investigating a new treatment for E. coli infections in stem cell transplant patients

A Phase 1b/2a, Randomized, Double-blind Study to Investigate Safety, Tolerability, PK, PD, and Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplantation Receiving Fluoroquinolone Prophylaxis and Harboring Fluoroquinolone-Resistant Escherichia Coli Pre-Transplant

This study is testing a new treatment called SNIPR001 to see if it can help prevent E. coli infections in patients with blood cancers who are getting stem cell transplants.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SNIPR Biome Aps. (Industry-sponsored)
• Locations: 8 sites (Duarte, California and 7 other locations)
• Trial ID: NCT06938867 on ClinicalTrials.gov

What this trial studies

This Phase 1b/2a study aims to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SNIPR001, a genetically modified bacteriophage targeting E. coli, in patients with hematologic malignancies scheduled for allogeneic hematopoietic stem cell transplant. Approximately 24 patients will be randomized to receive either SNIPR001 or a placebo alongside standard levofloxacin prophylaxis. Participants will be monitored for 100 days post-transplant to assess the treatment's effects on E. coli infections.

Who should consider this trial

Good fit: Ideal candidates include adults with hematologic malignancies who are scheduled for allogeneic stem cell transplants and are colonized with fluoroquinolone-resistant E. coli.

Not a fit: Patients who are not scheduled for allogeneic stem cell transplants or do not harbor fluoroquinolone-resistant E. coli may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce E. coli infections in vulnerable transplant patients, improving their overall outcomes.

How similar studies have performed: While this approach is novel, similar studies using bacteriophages have shown promise in treating bacterial infections.

Eligibility criteria

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 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.

Where this trial is running

Duarte, California and 7 other locations

• City of Hope — Duarte, California, United States (Recruiting)
• University of California, San Francisco — San Francisco, California, United States (Recruiting)
• John Hopkins University — Baltimore, Maryland, United States (Recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• Upmc — Pittsburgh, Pennsylvania, United States (Recruiting)
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Fred Hutchinson Cancer Center — Seattle, Washington, United States (Recruiting)

Conditions E Coli Infections; Allogenic Transplant Patients