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

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) accordingto 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:

7. Bone marrow reserve: Peripheral WBC < 25 × 10⁹/L (leukocyte-reducing agents areallowed, with a washout period of at least 5 half-lives prior to study drugadministration);

8. Coagulation: International normalized ratio (INR) ≤ 2;

9. 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;

10. Renal function: Creatinine clearance ≥60 mL/min (Cockcroft-Gault), or serumcreatinine ≤1.5 × ULN;

11. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤450 msfor males, ≤470 ms for females.

7. Female participants of childbearing potential and fertile male participantswith partners of childbearing potential must use medically approvedcontraception during treatment and for 6 months after the final dose.

Exclusion Criteria:

1. Known hypersensitivity to WBC100 capsules or any of their excipients;

2. Diagnosis of acute promyelocytic leukemia (APL);

3. Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blastcrisis, or AML transformed from myelodysplastic syndromes (MDS) ormyeloproliferative neoplasms (MPN);

4. Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensivechronic GVHD requiring immunosuppressive therapy, or autologous HSCT within thepast 90 days;

5. Subjects who have undergone major surgery, have active ulcers, or have unhealedwounds within 28 days prior to the first dose;

6. Received other investigational drugs or treatments within 28 days prior to thefirst administration, or are still within the safety follow-up period ofanother clinical trial;

7. Subjects with a history of severe cardiovascular or cerebrovascular conditions,including but not limited to:

8. Significant arrhythmias or conduction disorders (e.g., ventricular arrhythmias,Grade II-III AV block);

9. Thromboembolic events requiring anticoagulation or presence of vena cavafilter;

10. NYHA Class III-IV heart failure;

11. Poorly controlled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despitetreatment).

8. Evidence of severe or uncontrolled systemic diseases, such as refractoryeffusions, poorly controlled diabetes, or significant disorders of thepsychiatric, neurological, cardiovascular, respiratory, endocrine,gastrointestinal, hepatic, or renal systems;

9. History or presence of immunodeficiency, autoimmune disease requiring systemicimmunosuppressants, or organ transplantation;

10. Congestive heart failure, aortic dissection, stroke (excluding lacunarinfarct), unstable angina, myocardial infarction, bypass surgery, or pulmonaryembolism within 180 days prior to first dosing;

11. Known risk factors for QT prolongation, including congenital long QT syndromeor drug-induced arrhythmia history;

12. Positive for syphilis antibodies, HIV, active HBV infection (HBsAg+ or HBcAb+with HBV DNA ≥1000 IU/mL), or active HCV infection (HCV Ab+ with detectable HCVRNA);

13. Active infection requiring systemic treatment, including uncontrolledbacterial, viral, or fungal infections;

14. Gastrointestinal conditions preventing oral drug intake or absorption, such assevere vomiting, chronic diarrhea, intestinal stoma, malabsorption, orinability to swallow;

15. Use of strong CYP450 inhibitors/inducers that cannot be stopped ≥7 days beforedosing;

16. Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 daysfor localized radiotherapy), cytotoxic chemotherapy, targeted small moleculeswithin 14 days or 5 half-lives, or CAR-T therapy within 100 days;

17. Receipt of any live or attenuated vaccines (e.g., influenza, varicella) within 28 days;

18. History of other malignancies within 2 years, except adequately treated basalcell carcinoma, carcinoma in situ of cervix or breast, or squamous cellcarcinoma of the skin;

19. History of psychiatric or neurological disorders that may interfere withprotocol compliance;

20. Inability to tolerate venous blood draws;

21. Pregnant or breastfeeding women, or women with positive serum hCG duringscreening;

22. Any condition deemed by the investigator to make the subject unsuitable forstudy participation.