Clinical Trial Goal
To find out if SNIPR001 is safe and works well to prevent E. coli infection in patients with blood cancer receiving allogeneic BMT
You may be able to join this trial if you:
- Are 18 years old or older
- Have a blood cancer
- Are planning to receive allogeneic BMT
- Are being treated or will be treated with fluoroquinolone (levofloxacin). Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
SNIPR001 is a combination of 4 bacteriophages, created using CRISPR/Cas technology, that target E. coli bacteria in the gastrointestinal (GI) tract.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – SNIPR001 plus standard care
- Group 2 – Placebo plus standard care
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get:
- SNIPR001 – Group 1 only - A pill that you take by mouth 2 times each day
- Placebo – Group 2 only - A pill that you take by mouth 2 times each day
You may continue treatment for up to 1 month. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for about 3 months after BMT.
The Food and Drug Administration (FDA) has not yet approved SNIPR001.
Locations
Sponsors
collaborator: Bill and Melinda Gates Foundation, collaborator: Department of Health and Social Care (DHSC), UK, collaborator: Biomedical Advanced Research and Development Authority, collaborator: Wellcome Trust, collaborator: German Federal Ministry of Education and Research, lead: SNIPR Biome Aps.
