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

SNIPR Biome

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: E Coli Infections; Allogenic Transplant Patients

Treatments: Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli; Other: Placebo 10 mL

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT06938867

SNIPR001-002

Details and patient eligibility

About

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.

Full description

Patients scheduled for allo-HSCT will be pre-screened for the presence (in the gut) of FQR E. coli cultured from a perianal swab.

Approximately 24 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

SNIPR001 Active

Active Comparator group

Description:

12 patients on SNIPR001 (BID for up to 30 days)

Treatment:

Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli

Placebo

Placebo Comparator group

Description:

12 patients on Placebo (BID for up to 30 days)

Treatment:

Other: Placebo 10 mL