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.
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.
Single group
ICP-248
DrugEligible patients will receive ICP-248 orally as per the protocol
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)
Investigator-assessed ORR
According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).
According to Lugano 2014: IRC and investigator assessed duration of response (DOR).
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