A Clinical Trial of TQB3455 Tablets in Patients With Hematological Malignancies

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Aug 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3455, which is designed to help patients with blood cancers like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). The trial has two stages: the first stage focuses on understanding how safe and tolerable TQB3455 is when taken in pill form by patients with these conditions. The second stage will look at how effective TQB3455 is, either on its own or when combined with another medication called azacitidine.

To participate in this trial, patients need to be at least 18 years old and have been diagnosed with AML or MDS, specifically with a certain genetic mutation called IDH2. They should also meet specific health criteria, such as having a certain level of blood platelets and kidney function. Participants can expect to take the medication and be closely monitored for any side effects or changes in their condition. This trial is currently looking for new volunteers, and it's a chance for patients to potentially access a new treatment option while helping advance medical research.

Gender

ALL

Eligibility criteria

• 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:
• • 1. Difficult to treat or recurrent (\>5% of primitive cells reappear in the bone marrow after complete remission) AML; (Single drug group)
• • 2. 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):
• • 1. Extremely high-risk (\>6 points)
• • 2. High risk (\>4.5 points - ≤ 6 points)
• • 3. 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.