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.
≥ 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.
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.
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.