RecruitingPhase 2NCT07082686
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
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
68 participants
Start Date
Aug 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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
Min Age: 18 Years
Inclusion Criteria8
- ≥ 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 Criteria5
- 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.
Interventions
DRUGICP-248
Eligible patients will receive ICP-248 orally as per the protocol
Locations(29)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07082686