NCT06938867 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
| NCT ID | NCT06938867 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | SNIPR Biome Aps. |
| Condition | E Coli Infections |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-12-04 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 66 participants in total. It began in 2024-12-04 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. 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 duration of SNIPR001 dosing and for 28 days after the last dose of SNIPR001. 8. 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. 9. 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. Exclusion Criteria: 1. 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. 2. 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. 3. Have known hypersensitivity or allergy to any component of SNIPR001, levofloxacin and/or Alka-Seltzer treatment. 4. Unwilling or unable to comply with the requirements of this Protocol, including providing stool samples. 5. Female patients who are pregnant or lactating. 6. Have abnormal liver enzymes (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] \>2 × upper limit of normal \[ULN\] or total bilirubin \>1.5 × ULN). 7. Have hepatic disease associated with impaired liver function. 8. Have a history of Achilles tendinopathy or tendon rupture.
Frequently Asked Questions
Who can join the NCT06938867 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying E Coli Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06938867 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06938867 currently recruiting?
Yes, NCT06938867 is actively recruiting participants. Visit ClinicalTrials.gov or contact SNIPR Biome Aps. to inquire about joining.
Where is the NCT06938867 trial being conducted?
This trial is being conducted at Duarte, United States, San Francisco, United States, Baltimore, United States, Boston, United States and 6 additional locations.
Who is sponsoring the NCT06938867 clinical trial?
NCT06938867 is sponsored by SNIPR Biome Aps.. The trial plans to enroll 66 participants.