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

Inclusion Criteria:

• Males or females, of any race, aged ≥ 18 years.
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0- 2.
• Sufficient bone marrow function, hepatic function and Coagulation function.
• Patients must have measurable disease per disease-specific response criteria.
• Have histologically confirmed R/R CLL,SLL,MCL,Non-GCB DLBCL,FL(grade 1- 3a),MZL,WM.
• Received at least 2 prior systemic therapy and have no other therapies known toprovide clinical benefit.
• After the most recent treatment regimen, it is confirmed that PR has not beenachieved, or there is confirmed progressive disease.
• Must require systemic therapy.
• The pregnancy test (urine or serum) of female subjects of childbearing potential shallbe negative before enrollment.
• Female subjects of childbearing potential and fertile male subjects shall adopt one ofthe following highly effective contraception measures during the entire study andwithin 90 days after the study treatment is ended: abstinence, intrauterine device, orhormonal contraceptives beginning at least 3 months before the first dose of IMP.Malesubjects are prohibited from donating sperm from the start of study treatment to 90days after the end of treatment.

Exclusion Criteria:

• Subjects with central nervous system involvement.
• Subjects with histopathological transformation.
• Receipt of allogeneic hematopoietic stem cell transplantation ≤ 180 days before thestart of study treatment administration on Cycle 1, Day 1, unless the subject is nolonger on immunosuppressant medication. History of autologous hematopoietic stem celltransplantation 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 thefirst dose.
• Patients who have received BTKis, tyrosine kinase inhibitors or other targeted smallmolecule drugs for anti-tumor treatment within 7 days (or 5 half-lives, whichever isshorter) before initiation of study drug; or patients who have received any biologicaland/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 receivedsystemic chemotherapy, radiotherapy or traditional Chinese medicines with anti-tumoreffect (traditional Chinese medicines with anti-tumor indications specified in thepackage insert) within 2 weeks (or 5 half-lives, whichever is shorter).
• Previously developed toxicity due to anticancer treatment that did not resolve toGrade ≤ 1 (as per NCI-CTCAE 5.0), except for AEs not constituting a safety risk asassessed by the investigator.
• A history of other malignant tumors within 2 years before enrollment, except for basalcell carcinoma or skin squamous cell carcinoma having been adequately treated, orwithout disease for ≥ 2 years or with other types of cancer with the survival time ofgreater than 2 years. Subjects with breast or prostate cancer who are on maintenancehormonal therapies following therapeutic procedures with curative intent arepermitted.
• Uncontrolled systemic active infections, or other infections or still on intravenousanti-infection treatment.
• Underwent major surgery in the past 4 weeks.
• Known infection with human immunodeficiency virus, or serologic status reflectingactive 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 multigatedacquisition (MUGA) scan.
• QTcF ≥ 450 msecs for males and QTcF ≥ 470 msec for females or other significant ECGabnormalities.
• Clinically significant gastrointestinal abnormalities that may affect the intake,transport, or absorption of drugs.
• Requiring or received anticoagulant therapy with warfarin or equivalent vitamin Kantagonists (such as phenprocoumon) within 7 days before the first study treatment.
• Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura. Knownhistory of bleeding diathesis.
• A history of stroke or intracranial hemorrhage within 6 months before the first studytreatment.
• Use of CYP3A4 inhibitor or inducer within 7 days before the first study treatment, orusing of sensitive substrates metabolized by CYP3A4/CYP2B6.