NCT07014449 Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
| NCT ID | NCT07014449 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou Weben Pharma Co., Ltd |
| Condition | AML (Acute Myelogenous Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2024-11-03 |
| Primary Completion | 2026-06 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * 1\. Signed informed consent and compliance with study procedures; * 2\. Male or female participants aged ≥18 years at the time of consent; * 3\. Diagnosis of relapsed or refractory acute myeloid leukemia (R/R AML) according to the 2016 World Health Organization (WHO) classification; * 4\. ECOG PS 0-2; * 5\. Life expectancy ≥3 months; * 6\. Adequate bone marrow reserve and organ function as defined below: 1. Bone marrow reserve: Peripheral WBC \< 25 × 10⁹/L (leukocyte-reducing agents are allowed, with a washout period of at least 5 half-lives prior to study drug administration); 2. Coagulation: International normalized ratio (INR) ≤ 2; 3. Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. In cases of hepatic involvement: ALT or AST ≤ 5 × ULN, and TBIL ≤ 3 × ULN; 4. Renal function: Creatinine clearance ≥60 mL/min (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN; 5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤4
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