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Taking people in ChinaPhase 2

Tests ICP-248 in adults with relapsed or refractory mantle cell lymphoma

Tests the drug ICP-248 in adults whose mantle cell lymphoma returned or did not respond.

Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

Key facts

Where
Beijing, Changchun, Changsha, Chengdu, Chongqing, Fuzhou, Guangzhou, Hangzhou, Hefei, Hengyang, Jinan, Nanchang, Nanjing, Nanning, Qingdao, Shanghai, Tianjin, Wuhan, Xian, Xinjiang, Yibin, and Zhengzhou, ChinaSee the 29 sites
Phase
Phase 2

Where in China

  • Peking University Third HospitalBeijing, ChinaTaking people
  • The First Hospital of Jilin UniversityChangchun, ChinaTaking people
  • Hunan Cancer HospitalChangsha, ChinaTaking people
  • Sichuan Provincial People's HospitalChengdu, ChinaTaking people
  • West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
  • Chongqing University Cancer HospitalChongqing, ChinaTaking people
  • The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaTaking people
  • Fujian Medical University Union HospitalFuzhou, ChinaTaking people
  • Guangdong Provincial People's HospitalGuangzhou, ChinaTaking people
  • Sun Yat-sen University Cancer CenterGuangzhou, ChinaTaking people
  • The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
  • The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaTaking people
  • The First Affiliated Hospital of University of South ChinaHengyang, ChinaTaking people
  • Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
  • Shandong Cancer HospitalJinan, ChinaTaking people
  • Shandong Provincial Hospital Affiliated to Shandong First Medical UniversityJinan, ChinaTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaTaking people
  • Jiangsu Province HospitalNanjing, ChinaTaking people
  • Guangxi Medical University Cancer HospitalNanning, ChinaTaking people
  • The Affiliated Hospital of Qingdao UniversityQingdao, ChinaTaking people
  • Fudan University Shanghai Cancer CenterShanghai, ChinaTaking people
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesTianjin, ChinaTaking people
  • Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaTaking people
  • The Second Affiliated Hospital Of Xi'an Jiaotong UniversityXian, ChinaTaking people
  • The Affiliated Cancer Hospital of Xinjiang Medical UniversityXinjiang, ChinaTaking people
  • The Second People's Hospital of YibinYibin, ChinaTaking people
  • Henan Cancer HospitalZhengzhou, ChinaTaking people
  • Henan Provincial People's HospitalZhengzhou, ChinaTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Beijing InnoCare Pharma Tech Co., Ltd.
Trial code
NCT07082686
Record updated
23 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: ≥ 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: 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.

ClinicalTrials.gov NCT07082686