Efficacy and Safety of SHC014748M in Patients With Relapsed or Refractory Follicular (FL) or Marginal Zone (MZL) Lymphoma

Exclusion Criteria

• •Previous treatment with any PI3Kδ inhibitors.
• •Evidence of aggressive lymphoma(suspected clinical transformation should be conformed by biopsy).
• •Had any other anti-tumor treatment within 4 weeks prior to screening(including radiotherapy, chemotherapy, Chinese herbal anti-tumor treatment and major surgery); targeted therapy with 5 half-life period prior to screening.
• •Evidence of central nervous system involvement of the malignancy.
• •Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, uncontrolled pleural effusion and ascites, uncontrolled diabetes, severe or debilitating lung disease.
• •Any of the severe heart diseases, including New York Heart Association (NYHA) Class II or greater heart failure, arrhythmias requiring medical treatment, and history of myocardial infarction or unstable angina within 6 months prior to screening.Requiring any concomitant medication known to prolong the QT interval within 5 half-life period.
• •Evidence of active bacterial, fungal, or viral infection, and need systemic treatment.
• •Active infection with hepatitis B virus (HBV) (HBsAg positive, or HBsAg negative and HBV-DNA positive), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• •Concomitant use of any strong inhibitors or inducers of CYP3A4(except drug withdrawal prior to first dose of investigational drug.
• •Use of granulocyte colony-stimulating factor(G-CSF) or blood transfusion within 7 days before the hematology test at screening.
• •Prior autologous hematopoietic stem cell transplantation within 3 months prior to screening.
• •History of immune deficiency(acquired and congenital), or history of organ transplantation, or allogeneic bone marrow or hematopoietic stem cell transplantation; with active autoimmune disease or history of autoimmune disease including Interstitial pneumonia, autoimmune enteritis, autoimmune hepatitis and systemic lupus erythematosus
• •History of any uncured malignant tumor in the past five years except for the following: clinically cured cervical or breast carcinoma in situ, local basal cell or squamous cell carcinoma of the skin, thyroid tumor.
• •Inability to swallow the drug, or history of diseases affecting gastrointestinal functions significantly including malabsorption syndrome,bariatric surgery,inflammatory bowel disease, partial or complete intestinal obstruction.
• •Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0).
• •History of hypersensitivity to the main composition or any inactive excipient of the study drug.
• •Women who are breastfeeding.
• •With alcohol or drug abuse disorder.
• •History of stroke or intracranial hemorrhage with 6 months prior to screening.
• •Attenuated live vaccination within 4 weeks prior to screening.
• •With basic medical condition leading to risk of taking study drugs judged by investigators, or with confusion to toxicity and adverse events.
• •Judgment by the investigator that the patient should not participate in the study.