A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies

Exclusion Criteria

• •1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.
• •2. Use of systemic corticosteroids at doses equivalent to \>20 mg/day of prednisone for ≥3 days within 7 days prior to the first dose.
• •3. History of or currently suspected Richter's syndrome.
• •4. Known or suspected central nervous system (CNS) involvement.
• •5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.
• •6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.
• •7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.
• •8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.
• •9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.
• •10. Any severe and/or uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
• •11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.
• •12. Impaired cardiac function.
• •13. Any uncontrolled systemic infection.
• •14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.
• •15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.
• •16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.
• •17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.
• •18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.
• •19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.
• •20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.