SNIPR001 for E. coli Infections in Transplant Patients
This study is testing SNIPR001, a treatment made of genetically modified bacteriophages (viruses that infect bacteria), for people with blood cancers who are having an allogeneic hematopoietic stem cell transplant (a type of bone marrow transplant). You would be eligible if you are 18 or older, have a blood cancer, are planning to have this type of transplant, and will be taking levofloxacin (an antibiotic) to prevent infection. The main goals are to see how safe SNIPR001 is and how well your body tolerates it, as well as to look at early signs of how effective it might be. The study is currently unclear on its recruitment status.
- Study design
- This is a Phase 1b/2a study, meaning it's an early-stage trial. About 24 participants will be randomly assigned to receive either SNIPR001 or a placebo (an inactive substance) along with their standard antibiotic.
- What's involved
- Participants will be screened for a specific type of E. coli bacteria before the transplant. They will receive oral doses of SNIPR001 or placebo and will be followed for up to 100 days after their transplant.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 100 days after their allogeneic hematopoietic stem cell transplant.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
At a glance
Conditions
NCT06938867
Where you'd take part
This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
City of Hope
Duarte, Californiastudy coordinator listed
Recruiting
Fred Hutchinson Cancer Center
Seattle, Washingtonstudy coordinator listed
Recruiting
John Hopkins University
Baltimore, Marylandstudy coordinator listed
Recruiting
University of California, San Francisco
San Francisco, Californiastudy coordinator listed
Recruiting
University of Minnesota
Minneapolis, Minnesotastudy coordinator listed
Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texasstudy coordinator listed
Recruiting
UPMC
Pittsburgh, Pennsylvaniastudy coordinator listed
Recruiting
Weill Cornell Medicine
New York, New Yorkstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial 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 prophylaxisDay 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