Clinical Trial

Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia

Recruiting Phase 1
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Record status
This record was last updated June 11, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R/R AML). The main questions it aims to answer are: * What is the safety and tolerability profile of WBC100 in R/R AML patients? * Can WBC100 effectively induce remission in R/R AML patients? Participants will: * Take WBC100 capsules orally once daily in 28-day treatment cycles; * Undergo regular safety assessments, including adverse event monitoring and laboratory tests; * Provide blood samples for pharmacokinetic (PK) analysis; * Have their remission status and efficacy evaluated according to the ELN2022 criteria.
Trial Details
NCT Number NCT07014449
Lead Sponsor Hangzhou Weben Pharma Co., Ltd
Conditions AML (Acute Myelogenous Leukemia, Relapsed Acute Myelogenous Leukemia, Refractory Acute Myeloid Leukemia, Hematologic Malignancy, C-Myc, Adult Acute Myeloid Leukemia
Enrollment 18 participants
Start Date 2024-11-03
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-06-11