A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.

Inclusion Criteria:

• ≥ 18 years old.

• Histopathologically confirmed MCL expressing Cyclin D1 and/or t (11;14) chromosomal translocation.Formalin-fixed paraffin-embedded (FFPE) tissues or sections for diagnosis must be provided. It is for the approval of pathological diagnosis by the central pathology laboratory.

• The patient was diagnosed with relapsed or refractory mantle cell lymphoma, and the previous treatment needs to meet the following requirements:

  • Failure of at least one adequate prior line of anti-CD20-containing therapy;
  • Failure of at least one adequate prior line of BTK inhibitor (BTKi)-containing therapy.

• Failure of the last line of therapy.

• At least one measurable lesion according to the Lugano 2014 criteria,.

• ECOG performance status of 0-2 .

Exclusion Criteria

• Current or prior history of central nervous system (CNS) lymphoma.
• Prior use of BCL-2 inhibitors (e.g., venetoclax/ABT-199, etc.).
• Autologous stem cell transplantation or cellular therapy within 3 months prior to the first dose of ICP-248.
• Prior allogeneic hematopoietic stem cell transplantation.