A Study of HSK29116 in Adults With Relapsed/Refractory B-cell Malignancies

You may not qualify if:

• Subjects with central nervous system involvement.
• Subjects with histopathological transformation.
• Receipt of allogeneic hematopoietic stem cell transplantation ≤ 180 days before the start of study treatment administration on Cycle 1, Day 1, unless the subject is no longer on immunosuppressant medication. History of autologous hematopoietic stem cell transplantation within 12 weeks (84 days) before the start of study treatment.
• Continuous immunosuppressive therapy, including systemic (such as intravenous or oral) treatment with corticosteroids for the underlying diseases within 2 weeks before the first dose.
• Patients who have received BTKis, tyrosine kinase inhibitors or other targeted small molecule drugs for anti-tumor treatment within 7 days (or 5 half-lives, whichever is shorter) before initiation of study drug; or patients who have received any biological and/or immune-based anti-tumor treatment, including investigational treatment (including but not limited to monoclonal antibody therapy and/or anti-tumor vaccine) within 4 weeks (or 5 half-lives, whichever is shorter); or patients who have received systemic chemotherapy, radiotherapy or traditional Chinese medicines with anti-tumor effect (traditional Chinese medicines with anti-tumor indications specified in the package insert) within 2 weeks (or 5 half-lives, whichever is shorter).
• Previously developed toxicity due to anticancer treatment that did not resolve to Grade ≤ 1 (as per NCI-CTCAE 5.0), except for AEs not constituting a safety risk as assessed by the investigator.
• A history of other malignant tumors within 2 years before enrollment, except for basal cell carcinoma or skin squamous cell carcinoma having been adequately treated, or without disease for ≥ 2 years or with other types of cancer with the survival time of greater than 2 years. Subjects with breast or prostate cancer who are on maintenance hormonal therapies following therapeutic procedures with curative intent are permitted.
• Uncontrolled systemic active infections, or other infections or still on intravenous anti-infection treatment.
• Underwent major surgery in the past 4 weeks.
• Known infection with human immunodeficiency virus, or serologic status reflecting active hepatitis B or C infection.
• Subjects with severe cardiovascular diseases within 6 months before screening.
• Left Ventricular Ejection Fraction \< 50% based on either echocardiogram or multigated acquisition (MUGA) scan.
• QTcF ≥ 450 msecs for males and QTcF ≥ 470 msec for females or other significant ECG abnormalities.
• Clinically significant gastrointestinal abnormalities that may affect the intake, transport, or absorption of drugs.
• Requiring or received anticoagulant therapy with warfarin or equivalent vitamin K antagonists (such as phenprocoumon) within 7 days before the first study treatment.
• +3 more criteria