Status:
ACTIVE_NOT_RECRUITING
SYN-004 Safety and Tolerability in Allo-HCT Subjects
Lead Sponsor:
Theriva Biologics, Inc.
Collaborating Sponsors:
Washington University School of Medicine
Conditions:
Acute Graft-Versus-Host Reaction Following Bone Marrow Transplant
Prevention of CDI in Adult Patients Being Treated With IV Beta-lactam Antibiotics
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Study Objectives: 1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lacta...
Detailed Description
Study Design: This is a single-center, placebo controlled, double blinded Phase 1b/2a study to assess the safety, tolerability and potential efficacy of orally administered SYN-004 in adult allo-HCT ...
Eligibility Criteria
Inclusion
- Participant provides written informed consent.
- Male or female patients ≥18 years undergoing myeloablative allo-HCT for a hematologic malignancy or myeloproliferative disorder.
- Participant is able to ingest the SYN-004 dosage form (size 0 hard capsule).
Exclusion
- Allergy(ies) to MER, PIP, TAZO, or FEP.
- History of allergy to SYN-004 or its components.
- Admitted for HCT and started on MER, PIP/TAZO, or FEP prior to enrollment in the present study.
- Currently enrolled in another interventional clinical study or received an investigational drug or device within 30 days or within a time period consistent with a washout period of 5 half-lives before signing the Informed Consent Form, whichever is longer.
- Recipients of umbilical cord blood transplantation.
- Underlying condition requiring HCT is not in remission (per International Working Group definitions), except for myelodysplastic syndrome and lymphoma, as long as these conditions are chemotherapy responsive.
- Creatinine clearance \<60 mL/min/1.73 m² by Cockroft-Gault calculation.
- Cardiac ejection fraction \<50%.
- Cirrhosis, bilirubin \>1.5x upper limit of normal, or AST/ALT \>2.5x upper limit of normal.
- History of veno-occlusive disease (VOD) or hepatic sinusoidal obstructive syndrome (SOS).
- DLCO and/or FEV1 ≤80% of normal.
- Chronic HIV or HBV infection.
- Invasive fungal infection not responding to treatment at time of HCT.
- Known active bacterial or viral infection at time of HCT.
- CDI in the preceding 6 months.
- Unable to comply with study protocol as determined by primary investigator.
- Active gastrointestinal (GI) bleeding at time of HCT.
- Prior colectomy or short gut syndrome.
- Pregnant or breast feeding.
Key Trial Info
Start Date :
February 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04692181
Start Date
February 15 2021
End Date
December 1 2026
Last Update
January 6 2025
Active Locations (1)
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1
Washington University
St Louis, Missouri, United States, 63110