SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coliPlacebo 10 mL
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli: SNIPR001 is a live biotherapeutic product
Placebo 10 mL: Placebo 10 mL matching to SNIPR001 will be administered.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 — Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8 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 mortality (NRM)
4. Incidence of all-cause mortality
5. Incidence of primary graft failure and secondary graft failure
6. Incidence of acute graft versus host disease (aGvHD)
7. Incidence of Clostridioides difficile (C. difficile) diarrhea
8. Median number of days from transplant to onset of neutropenic fever
Trial sites (8)
Facility
City
Region
Status
City of Hope
Duarte
California
Recruiting
University of California, San Francisco
San Francisco
California
Recruiting
John Hopkins University
Baltimore
Maryland
Recruiting
University of Minnesota
Minneapolis
Minnesota
Recruiting
Weill Cornell Medicine
New York
New York
Recruiting
UPMC
Pittsburgh
Pennsylvania
Recruiting
University of Texas MD Anderson Cancer Center
Houston
Texas
Recruiting
Fred Hutchinson Cancer Center
Seattle
Washington
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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