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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
| Department of Health and Social Care, UK | OTHER |
| Biomedical Advanced Research and Development Authority | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNIPR001 Active | Active Comparator | 12 patients on SNIPR001 (BID for up to 30 days) |
|
| Placebo | Placebo Comparator | 12 patients on Placebo (BID for up to 30 days) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNIPR001 consists of genetically modified bacteriophages specifically targeting Escherichia coli | Biological | SNIPR001 is a live biotherapeutic product |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Day 30 and 100 for endpoints 1-7 and 1-2 weeks for endpoint 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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| Wellcome Trust |
| OTHER |
| German Federal Ministry of Education and Research | OTHER_GOV |
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| Placebo 10 mL | Other | Placebo 10 mL matching to SNIPR001 will be administered. |
|
Change in E. coli relative abundance in stool |
| 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 | 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. | 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 |
| From the first dose of randomized treatment through 30 days after transplant. |
| University of California, San Francisco | Recruiting | San Francisco | California | 94118 | United States |
|
| John Hopkins University | Recruiting | Baltimore | Maryland | 21218 | United States |
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| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
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| Weill Cornell Medicine | Recruiting | New York | New York | 10065 | United States |
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| UPMC | Recruiting | Pittsburgh | Pennsylvania | 15213-2582 | United States |
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| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Fred Hutchinson Cancer Center | Recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D004927 | Escherichia coli Infections |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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