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 .
You may not be if
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.