A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)

Recruiting now · Phase 2

Conditions studied: Relapsed or Refractory Mantle Cell Lymphoma (MCL)

In brief

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.

Key facts

Study ID

NCT07082686

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

75

Starts

2025-08-21

Expected to finish

2028-07-01

Last updated by the study team

2026-07-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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 .

You may not qualify 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.
• Prior allogeneic hematopoietic stem cell transplantation.

Where it is running

• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Chengdu, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Guangxi Medical University Cancer Hospital — Nanning, Guangxi, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Hunan Cancer Hospital — Changsha, Hunan, China (enrolling)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (enrolling)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (enrolling)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (enrolling)
• The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (enrolling)
• Shandong Cancer Hospital — Jinan, Shandong, China (enrolling)
• The Affiliated Hospital of Qingdao University — Qingdao, Shandong, China (enrolling)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• The Second Affiliated Hospital of Xi'an Jiaotong University — Xian, Shanxi, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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