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).

A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)

This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).

Inclusion Criteria:

1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
2. 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.
3. Patients with other malignancies within 2 years prior to enrollment.
4. Uncontrolled or significant cardiovascular disease.
5. 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.
6. Participants with severe central nervous system diseases.
7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
8. Underwent major surgery within 4 weeks prior to the first dose.
9. Active infections require systemic treatment.
10. Active autoimmune diseases.
11. Known central nervous system lymphoma.
12. Known alcohol or drug dependence.

Exclusion Criteria:

1. Known intolerance to orelabrutinib or pirtobrutinib treatment.
2. 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.
3. Patients with other malignancies within 2 years prior to enrollment.
4. Uncontrolled or significant cardiovascular disease.
5. 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.
6. Participants with severe central nervous system diseases.
7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
8. Underwent major surgery within 4 weeks prior to the first dose.
9. Active infections require systemic treatment.
10. Active autoimmune diseases.
11. Known central nervous system lymphoma.
12. Known alcohol or drug dependence.