Overview

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.

Eligibility

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

• Blastoid or pleomorphic mantle cell lymphoma (MCL).
• 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.