NCT06938867 · SNIPR Biome Aps.
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 PreTransplant
What this study is about
This is a Phase 1b/2a study in allogenic hematopoetic stem cell transplant patients to investigate the safety, PK, PD and preliminary effectiveness of multiple taken by mouth administrations of SNIPR001 when given concomitantly with SoC levofloxacin.
View original scientific description
This is a Phase 1b/2a study in allogenic hematopoetic 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.
Interventions
BIOLOGICAL
SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli
SNIPR001 is a live biotherapeutic product
OTHER
Placebo 10 mL
Placebo 10 mL matching to SNIPR001 will be administered.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Where
- Duarte, California
- San Francisco, California
- Baltimore, Maryland
- Minneapolis, Minnesota
- New York, New York
- Pittsburgh, Pennsylvania
- Houston, Texas
- Seattle, Washington
Collaborators
Bill and Melinda Gates Foundation, Department of Health and Social Care, UK, Biomedical Advanced Research and Development Authority, Wellcome Trust, German Federal Ministry of Education and Research
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 14, 2025 · Source of record for eligibility and locations