OncoMatch/Clinical Trials/NCT07014449
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
Is NCT07014449 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies WBC100 QD for aml (acute myelogenous leukemia.
Treatment: WBC100 QD — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: allogeneic hematopoietic stem cell transplant
Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days
Cannot have received: autologous hematopoietic stem cell transplant
autologous HSCT within the past 90 days
Cannot have received: investigational drug or treatment
Received other investigational drugs or treatments within 28 days prior to the first administration, or are still within the safety follow-up period of another clinical trial
Cannot have received: monoclonal antibody
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: antibody-drug conjugate
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: radiation therapy
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: cytotoxic chemotherapy
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: targeted small molecule
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: CAR-T cell therapy
Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days
Cannot have received: live or attenuated vaccine
Receipt of any live or attenuated vaccines (e.g., influenza, varicella) within 28 days
Lab requirements
Blood counts
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)
Kidney function
creatinine clearance ≥60 ml/min (cockcroft-gault), or serum creatinine ≤1.5 × uln
Liver 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
Cardiac function
left ventricular ejection fraction (lvef) ≥50%; qtcf ≤450 ms for males, ≤470 ms for females
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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