A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

Inclusion criteria

Patients meeting all of the following inclusion criteria can be included in this trial:

• Age ≥ 18 years old;
• According to the World Health Organization (WHO) classification, subjects diagnosed with myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) should meet one of the following criteria:

• Difficult to treat or recurrent (>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
• Newly diagnosed AML subjects recognized by researchers as unable to receive standard treatment due to age, physical condition, or risk factors; (Joint group)
• MDS subjects belong to the following prognostic risk categories according to the revised International Prognostic Scoring System (IPSS-R):

• Extremely high-risk (>6 points)
• High risk (>4.5 points - ≤ 6 points)
• Medium risk (>3 points - ≤ 4.5 points)
• Clearly indicating the presence of IDH2 gene mutation;
• Blood platelet (PLT) ≥20×10^9/L； Or subjects with PLT<20 × 10^9/L, but recognized by the researchers as being caused by tumor reasons;
• Serum total bilirubin ≤ 1.5 × ULN (for Gilbert syndrome subjects, bilirubin ≤ 3 × ULN);
• Renal function: serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 50ml/min;
• Recovery of toxic reactions caused by surgery, radiation therapy, or other anti-tumor treatments to ≤ Grade I;
• Women should agree to use contraceptive measures during the study period and within 6 months after the end of the study; Male participants must agree to use contraception during the study period and within 6 months after the end of the study period;
• The subjects voluntarily joined this study.

Exclusion criteria

• Subjects who experience relapse after bone marrow transplantation;
• Subjects who have received systemic anti-tumor therapy or radiation therapy within 3 weeks prior to the use of the investigational drug;
• Individuals who have participated in clinical trials of other drugs within the four weeks prior to using the investigational drug;
• Individuals with multiple factors that affect oral medication, such as inability to swallow, post gastrointestinal resection, chronic diarrhea, and intestinal obstruction;
• Subjects who have previously used targeted isocitrate dehydrogenase 2 (IDH2) inhibitors;
• The subject has uncontrolled systemic fungal, bacterial, or viral infections;
• High blood pressure subjects who are still poorly controlled despite drug treatment;
• Obvious cardiovascular diseases, such as heart failure classified as grade 2 or above by the New York Heart Association (NYHA), unstable angina in the past 3 months, myocardial ischemia or infarction, arrhythmia and grade I heart failure, or the presence of other factors at risk of prolonging the QT interval (such as arrhythmia, hypokalemia ≥ grade 3, family history of long QT interval);
• Severe leukemia complications that endanger life, such as uncontrolled bleeding, hypoxia or shock pneumonia, disseminated intravascular coagulation;
• Subjects known to have central nervous system leukemia or clinical symptoms of central nervous system leukemia;
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
• Subjects with active replication of hepatitis B virus and hepatitis C virus;
• Individuals with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
• According to the researcher's judgment, there are accompanying diseases that pose a serious threat to the safety of the subjects or affect their ability to complete the study.