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
1 other identifier
interventional
75
1 country
29
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2025
Typical duration for phase_2
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2025
CompletedFirst Posted
Study publicly available on registry
July 24, 2025
CompletedStudy Start
First participant enrolled
August 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
April 27, 2026
April 1, 2026
2.3 years
July 15, 2025
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
3 years
Secondary Outcomes (15)
According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)
3 years
Investigator-assessed ORR
3 years
According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).
3 years
According to Lugano 2014: IRC and investigator assessed duration of response (DOR).
3 years
According to Lugano 2014: IRC and investigator assessed time to initial response (TTR).
3 years
- +10 more secondary outcomes
Study Arms (1)
ICP-248Tablets
EXPERIMENTALInterventions
Eligibility Criteria
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:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100919, China
West China Hospital of Sichuan University
Chengdu, Chengdu, 610041, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510050, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530012, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451191, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210036, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, 710004, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The Affiliated Cancer Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, 830000, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2025
First Posted
July 24, 2025
Study Start
August 21, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
April 27, 2026
Record last verified: 2026-04