Actively Recruiting
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
Led by Hangzhou Weben Pharma Co., Ltd · Updated on 2025-06-11
18
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and agreement to follow study procedures
- Male or female aged 18 years or older at time of consent
- Diagnosed with relapsed or refractory acute myeloid leukemia per 2016 WHO classification
- ECOG performance status of 0 to 2
- Life expectancy of at least 3 months
- Adequate bone marrow reserve with peripheral WBC less than 25 x 10^9/L
- Coagulation with INR less than or equal to 2
- Liver function with total bilirubin less than or equal to 1.5 times ULN, ALT and AST less than or equal to 2.5 times ULN (or up to 5 times ALT/AST and 3 times bilirubin if liver involved)
- Kidney function with creatinine clearance of at least 60 mL/min or serum creatinine less than or equal to 1.5 times ULN
- Heart function with left ventricular ejection fraction at least 50% and QTcF less than or equal to 450 ms for males and 470 ms for females
- Women of childbearing potential and fertile men with partners of childbearing potential must use medically approved contraception during treatment and for 6 months after last dose
You will not qualify if you...
- Known allergy or sensitivity to WBC100 capsules or their ingredients
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML transformed from myelodysplastic syndromes or myeloproliferative neoplasms
- Relapse after allogeneic stem cell transplant with grade 2 or higher acute GVHD or extensive chronic GVHD requiring immunosuppressive therapy, or autologous stem cell transplant within past 90 days
- Major surgery, active ulcers, or unhealed wounds within 28 days before first dose
- Use of other investigational drugs or treatments within 28 days before first dose or still in safety follow-up from another trial
- History of severe cardiovascular or cerebrovascular diseases including serious arrhythmias, thromboembolic events requiring anticoagulation, severe heart failure, or poorly controlled high blood pressure
- Severe or uncontrolled systemic diseases such as refractory effusions, poorly controlled diabetes, or major disorders of several organ systems
- History or presence of immunodeficiency, autoimmune disease needing systemic immunosuppressants, or organ transplant
- Recent serious heart events like congestive heart failure, aortic dissection, stroke, unstable angina, heart attack, bypass surgery, or pulmonary embolism within 180 days
- Known risk factors for QT prolongation including congenital long QT syndrome or drug-induced arrhythmia
- Positive tests for syphilis, HIV, active hepatitis B or C infection
- Active infections requiring systemic treatment
- Gastrointestinal problems preventing oral drug intake or absorption
- Use of strong CYP450 inhibitors or inducers that cannot be stopped at least 7 days before dosing
- Recent receipt of monoclonal antibodies, antibody-drug conjugates, radiotherapy, chemotherapy, targeted small molecules, or CAR-T therapy within specified timeframes
- Receipt of any live or attenuated vaccines within 28 days
- History of other cancers within 2 years except certain treated skin or cervical cancers
- Psychiatric or neurological conditions that may affect compliance
- Inability to tolerate blood draws
- Pregnant or breastfeeding women or positive pregnancy test at screening
- Any condition that the investigator judges makes participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
B
Biao Zhang, Ph.D.
CONTACT
B
Baorui Kong, M.Med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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