Clinical Study of TQB2618 Injection in Combination With Demethylation Drugs in Patients With Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes

This is an interventional treatment trial for Recurrent/Refractory Acute Myeloid Leukemia, Myelodysplastic Syndromes Read More

Inclusion Criteria:

• 1 Subjects with medium-high risk recurrent/refractory International Prognostic Scoring System (IPSS-R) myelodysplastic syndromes(MDS) and acute myelocytic leukemia(AML) clearly diagnosed by pathology, who were intolerant to other medications and judged by the investigator to have no other appropriate treatment.
• 2 ≥18 years old; Eastern Cooperative Oncology Group (ECOG) physical status: 0-2; at least 3 months expected survival period.
• 3 The function of main organs is normal.
• 4 Subjects must need to adopt effective methods of contraception.
• 5 Subjects voluntarily joined the study, signed informed consent form, and with good compliance.

Exclusion Criteria:

• 1 Patients has had or is currently having other malignant tumors within 3 years. The following two conditions can be included in the group: other malignant tumors treated with a single operation to achieved 5 consecutive years of disease free survival (DFS)s. Cured cervical carcinoma in situ, non-melanoma skin cancer, nasopharyngeal carcinoma and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)].
• 2 Patients diagnosed with acute promyelocytic leukemia or Philadelphia Chromosome-Positive Acute Myeloid Leukemia (Ph+AML) , or low-risk relapsed and refractory AML who only received second-line therapy;
• 3 The non-hematologic toxicity of previous antitumor treatment is not recovered to ≤ grade 1 (excluding hair loss).
• 4 Received major surgical treatment, open biopsy or obvious traumatic injury within 4 weeks before treatment.
• 5 The subjects had any history of bleeding or coagulopathy or who were being treated with anticoagulant.
• 6 Subjects had an arteriovenous thrombosis event within 6 months.
• 7 History of drug abuse, alcohol or drug abuse or mental disorder. Subjects who have epilepsy and require treatment.
• 8 Poor blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg);
• 9 Subjects who had received allogeneic stem cell transplantation or autologous stem cell transplantation within 3 months；
• 10 Subjects with ≥ grade 2 myocardial ischemia or infarction, arrhythmia, prolonged QTc interval (including male QTc ≥450ms, female QTc ≥470ms) and ≥ grade 2 congestive heart failure with New York Heart Association (NYHA )classification；
• 11 Active or uncontrolled severe infection ≥common terminology criteria for adverse events （CTCAE） grade 2 infection)；
• 12 Subjects with active hepatitis.
• 13 The subjects was diagnosed with renal failure and required hemodialysis or peritoneal dialysis.
• 14 History of immunodeficiency, including positive human immunodeficiency virus (HIV) test or other acquired, congenital immunodeficiency disease, or history of organ transplantation.
• 15 Poor control of diabetes (fasting glucose GLU > 10mmol/L);
• 16 Subjects who have received radiation therapy or the treatment of proprietary Chinese medicines with anti-tumor indications clearly stated in the National Medical Products Administration (NMPA) approved drug instructions within 4 weeks of starting treatment.
• 17 Uncontrolled pleural effusion, pericardial effusion or ascites;
• 18 Subjects with central nervous system aggression;
• 19 Vaccination history of live attenuated vaccine before 4 weeks of starting treatment, or planned vaccination of live attenuated vaccine during the study period.
• 20 History of severe allergy to study drugs and pharmaceutical excipients .
• 21 Subjects diagnosed with active autoimmune disease within 2 years before starting treatment.
• 22 Receiving any other investigational agent within 4 weeks before first dose.
• 23 According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study.