A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).

Inclusion criteria

• Known intolerance to orelabrutinib or pirtobrutinib treatment.
• Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
• Patients with other malignancies within 2 years prior to enrollment.
• Uncontrolled or significant cardiovascular disease.
• Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
• Participants with severe central nervous system diseases.
• Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
• Underwent major surgery within 4 weeks prior to the first dose.
• Active infections require systemic treatment.
• Active autoimmune diseases.
• Known central nervous system lymphoma.
• Known alcohol or drug dependence.

Exclusion criteria

• Known intolerance to orelabrutinib or pirtobrutinib treatment.
• Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
• Patients with other malignancies within 2 years prior to enrollment.
• Uncontrolled or significant cardiovascular disease.
• Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
• Participants with severe central nervous system diseases.
• Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
• Underwent major surgery within 4 weeks prior to the first dose.
• Active infections require systemic treatment.
• Active autoimmune diseases.
• Known central nervous system lymphoma.
• Known alcohol or drug dependence.