E Coli InfectionsPhase 1/2NCT06938867
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 1/2 study testing SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli in people with E Coli Infections and Allogenic Transplant Patients, run by SNIPR Biome Aps. at 10 sites in United States.
Trial 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. The study consists of two parts. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E Coli Infections, Allogenic Transplant Patients
- What is being tested?
- SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 10 sitesUnited States
- Study dates
- 4 Dec 2024to Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 years of age at the time of consent.
- Patient is able and willing to provide written informed consent prior to any study-related procedure.
- Confirmed diagnosis of any hematologic malignancy.
- Planned to undergo an allogeneic hematopoietic stem cell transplant.
- Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
- 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 +/-).
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- 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.
- 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.
- 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.
Who cannot join
- 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.
- 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.
- Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer treatment.
- Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
- Female patients who are pregnant or lactating.
- Have abnormal liver enzymes (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >2 × upper limit of normal [ULN] or total bilirubin >1.5 × ULN).
- Have hepatic disease associated with impaired liver function.
- Have a history of Achilles tendinopathy or tendon rupture.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
United States10 sites, 10 recruiting
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21218
Dr Veronica Dioverti, (410) 516-8000, OCT@jh.edu
- Not yet recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Jessica Litter, 617-632-3000, mshehata2@mgb.org
- Recruiting
City of Hope
Duarte, California, 91010
Dr Deepa Nanayakarra, 626-275-8069, flewis@coh.org
- Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dr. George Chen, (877) 632-6789, jrbigcal@mdanderson.org
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Dr Jo-Anne Young, 612-626-3500, sfinder@umn.edu
- Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Ying Taur, 646-738-9151, mangarl@mskcc.org
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Dr Michael Satlin, 646-962-8215, jctosrc@med.cornell.edu
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213-2582
Dr Will Garner, (412) 648-6377, snookse@upmc.edu
- Recruiting
University of California, San Francisco
San Francisco, California, 94118
Dr Sarah Doernberg, (415) 476-1000, airway@ucsf.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Dr Catherine Liu, 855-557-0555, catherine.liu@fredhutch.org
About this study
Official title: 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 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. The study consists of two parts. Part 1 will include 24 randomized and dosed patients. Part 2 will be added with amendment 3 and will include 42 randomized and dosed patients. Thus, approximately 66 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.
Read the detailed 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. Part 1 has been completed and Part 2 has been initiated.
- Conditions
- E Coli Infections, Allogenic Transplant Patients
- Being tested
- SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli, Placebo 10 mL
- Medical subject headings
- Escherichia coli Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coliBiological
SNIPR001 is a live biotherapeutic product
Placebo 10 mLOther
Placebo 10 mL matching to SNIPR001 will be administered.
| Study group | Role | What they receive |
|---|---|---|
| SNIPR001 Active | Active comparator | 33 patients on SNIPR001 (BID for up to 30 days) Receives: Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli |
| Placebo | Placebo comparator | 33 patients on Placebo (BID for up to 30 days) Receives: Other: Placebo 10 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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.
- Time to neutrophil recovery (defined as the 1st day of ANC ≥0.5x109/L for 3 consecutive days)
- Incidence of non-relapse mortality (NRM)
- Incidence of all-cause mortality
- Incidence of primary graft failure and secondary graft failure
- Incidence of acute graft versus host disease (aGvHD)
- Incidence of Clostridioides difficile (C. difficile) diarrhea
- Median number of days from transplant to onset of neutropenic fever
Measured: Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8
Secondary outcomes (5)
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Proportion of patients with an increase in E. coli relative abundance in stool
Measured: Baseline and last day of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Change in E. coli relative abundance in stool
Measured: Day-2 to end of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Change in E. coli absolute abundance
Measured: Day-2 to end of dosing
To assess the pharmacokinetics (PK) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Recovery of SNIPR001 from first dose of randomized treatment through 7 days after last dose randomized treatment in stool, blood and urine based on the number of plaque-forming units (PFUs) per gram in stool, and the number of PFUs per milliliter in blood and urine.
Measured: From first dose of randomized treatment through 7 days after last dose of randomized treatment in stool, blood and urine
To assess the preliminary efficacy of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
- Proportion of patients with E. coli bloodstream infections (BSIs) assessed from the first dose of randomized treatment through 30 days after transplant.
- Proportion of patients with gram-negative BSIs only, assessed from first dose of randomized treatment through 30 days after transplant.
- Proportion of patients with gram-positive BSIs only, assessed from first dose of randomized treatment through 30 days after transplant.
- Total BSIs assessed from first dose of randomized treatment through 30 days after transplant.
- Incidence and number of neutropenic fever episodes from first dose of randomized treatment through 30 days after transplant.
- Incidence and number of patients receiving broad-spectrum antibiotics on suspicion of a bloodstream infection
Measured: From the first dose of randomized treatment through 30 days after transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start4 Dec 2024
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E Coli InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SNIPR Biome Aps.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- U.S. Health and Human Services and Biomedical Advanced Research and Development Authority, The European Commission's DG Health Emergency Preparedness and Response Authority (DG HERA) and KfW Development Bank, Italy's Ministry of Economy and Finance, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), Wellcome Trust, Novo Nordisk Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938867
- Sponsor's protocol ID
- SNIPR001-002
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06938867
- Acronym / sponsor ID
- SNIPR001-002
- Conditions
- E Coli Infections, Allogenic Transplant Patients
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- SNIPR Biome Aps.Industry (pharma, biotech, devices)
- Collaborators
- U.S. Health and Human Services and Biomedical Advanced Research and Development Authority, The European Commission's DG Health Emergency Preparedness and Response Authority (DG HERA) and KfW Development Bank, Italy's Ministry of Economy and Finance, CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator), Wellcome Trust, Novo Nordisk Foundation
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. The study consists of two parts. Part 1 will include 24 randomized and dosed patients. Part 2 will be added with amendment 3 and will include 42 randomized and dosed patients. Thus, approximately 66 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.
Detailed 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. Part 1 has been completed and Part 2 has been initiated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SNIPR001 Active | Active comparator | Biological: SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli33 patients on SNIPR001 (BID for up to 30 days) |
| Placebo | Placebo comparator | Other: Placebo 10 mL33 patients on Placebo (BID for up to 30 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥18 years of age at the time of consent.
- Patient is able and willing to provide written informed consent prior to any study-related procedure.
- Confirmed diagnosis of any hematologic malignancy.
- Planned to undergo an allogeneic hematopoietic stem cell transplant.
- Patient is scheduled to receive fluoroquinolone (levofloxacin) prophylaxis.
Key exclusion criteria (8 listed)
- 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.
- 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.
- Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer treatment.
- Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples.
- Female patients who are pregnant or lactating.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coliSNIPR001 is a live biotherapeutic product | Biological | SNIPR001 Active |
| Placebo 10 mLPlacebo 10 mL matching to SNIPR001 will be administered. | Other | Placebo |
Primary outcome
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
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
5 secondary outcomes
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Time frame: Baseline and last day of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Time frame: Day-2 to end of dosing
To assess the pharmacodynamics (PD) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Time frame: Day-2 to end of dosing
To assess the pharmacokinetics (PK) of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Time frame: From first dose of randomized treatment through 7 days after last dose of randomized treatment in stool, blood and urine
To assess the preliminary efficacy of SNIPR001 in all patients who receive SNIPR001 or placebo in combination with SoC levofloxacin prophylaxis
Time frame: From the first dose of randomized treatment through 30 days after transplant.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli in people with E Coli Infections and Allogenic Transplant Patients, run by SNIPR Biome Aps. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.