A Study of TQB3454 Tablets in Patients With Blood Tumors

Inclusion Criteria:

• Patients voluntarily joined the study and signed informed consent with goodcompliance.
• Men and women; The expected survival is ≥3 months.
• Negative serum/urine pregnancy test within 7 days prior to initial dose and must benon-lactating; Women of childbearing age agree to use contraception (such as anintrauterine device, birth control pill or condom) during the study and for six monthsafter the study completion; Men agreed to use contraception during the study periodand for six months after the end of the study.
• The major organs are functioning well;
• For Relapsing/refractory acute myeloid leukemia (AML):

1. According to the classification criteria for Hematopoietic and lymphoid tissuetumors revised by the World Health Organization (WHO) in 2016, AML confirmed bybone marrow cell morphology, excluding acute promyelocytic leukemia (APL).
2. ≥18 years old; Eastern Cooperative Oncology Group (ECOG) score is 0~2.
3. Blood biochemical examination: i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases; ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT and AST≤5×ULN if liverinfiltration was associated.

• For myelodysplastic syndrome (MDS) with higher risk:

1. MDS patients were confirmed by bone marrow cell morphology and cytogenetics andmet the classification criteria of hematopoietic and lymphoid tissue tumorsrevised by WHO in 2016.
2. ≥18 years old; ECOG score is 0~2. c. Blood biochemical examination: i: Total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN), liver infiltration ≤3×ULN in Gilbert syndrome patients or tumor diseases. ii: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; ALT andAST≤5×ULN if concomitant with liver infiltration.

Exclusion Criteria:

• Tumor diseases and history:

1. The tumor has or is suspected to involve the central nervous system, or primaryCentral nervous system leukemia.
2. Present or present with other malignant tumors within 3 years prior to the firstdose. Except the following conditions: for other malignancies treated with asingle operation, achieving a 5-year continuous disease-free survival (DFS);Cured cervical carcinoma in situ, non-melanoma skin cancer, and superficialbladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumorinfiltrating basal membrane)].
3. Severe life-threatening complications of leukemia, such as uncontrolled bleeding,hypoxia or shock pneumonia, and disseminated intravascular coagulation.

• Previous antitumor therapy:

1. Received National Medical Products Administration (NMPA) approved Chinese patentdrugs with anticancer indications specified in the drug label within 2 weeksprior to initial administration.
2. Toxicities associated with previous antineoplastic therapy did not return toCTCAE≤1, except for hair loss, fatigue and poor appetite.
3. Associated diseases and history:
4. Abnormal liver.
5. Renal abnormalities.
6. Gastrointestinal abnormalities.
7. Cardio-cerebrovascular abnormalities.
8. Immune-related history.
9. Lung disease.
10. Comorbidities that were severe or poorly controlled and, in the investigator'sjudgment, significantly compromised patient safety or hindered study completion.
11. Risk of bleeding.

• History of drug abuse or drug abuse.
• Participated in clinical trials of other drugs within the past 30 days;
• It is estimated that the patient's compliance to participate in this clinical study isinsufficient.