Study of APG2575 Single Agent and Combination Therapy in Patients With Relapsed/Refractory CLL/SLL

Exclusion Criteria20

• Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy within 24 months or autologous hematopoietic stem cell transplantation within 12 months.
• Monoclonal antibody therapy against CLL was adopted within 4 weeks prior to the first dose of the study drug.
• Receive any of the following treatments within 14 days or 5x half-life before the first dose of study drug, or clinically significant adverse reactions / toxicities due to previous treatments have not recovered to ≤ Grade 1: Anti-tumor therapies include chemotherapy, radiotherapy, anti-tumor steroid treatment, anti-tumor Chinese medicine treatment; investigational treatment, including targeted small molecule drugs.
• Use the following drugs within 14 days before the first dose of study drug: moderately potent CYP3A inhibitors such as fluconazole, ketoconazole and clarithromycin; moderately potent CYP3A inducers such as rifampin, carbamazepine, phenytoin And St. John's wort.
• Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry.
• Received Bcl-2 inhibitor treatment.
• Invasive NHL transformation or central nervous system (CNS) involvement. has occurred.
• Cardiovascular disease of grade ≥2 (New York Heart Association Class).
• A significant history of renal, neurological, psychiatric, pulmonary, endocrine, metabolic, immune, cardiovascular or liver disease. The investigator believes that participating in this study will have an adverse effect on him / her. For subjects requiring intervention for any of the above diseases in the past 6 months, the investigator and the sponsor must discuss.
• Warfarin or other anticoagulants is required.
• Known to be allergic to study drug ingredients or their analogues.
• Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment.
• Within 3 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that:
• Fully treated cervical carcinoma in situ;
• Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
• confinement and resection of previously cured malignancies (or other treatment).
• Has malabsorption syndrome or other conditions that are not suitable for enteral administration.
• Uncontrolled other clinically significant symptoms, including but not limited to: uncontrolled systemic infections (viruses, bacteria, or fungi), including but not limited to known hepatitis B virus (HBV) surface antigens and DNA positive(HBV-DNA≥2000copies/mL or ≥500IU/mL); Hepatitis C virus (HCV) antibody positive or RNA positive; human immunodeficiency virus (HIV) antibody positive; Febrile neutropenia occured within 1 week before administration.
• Primary active autoimmune diseases and connective tissue diseases, such as active and uncontrolled primary autoimmune hemocytopenia, including autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP).
• Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.