OncoMatch/Clinical Trials/NCT07014449
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
Is NCT07014449 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07014449 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic hematopoietic stem cell transplant, autologous hematopoietic stem cell transplant, investigational drug or treatment disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify