Actively Recruiting
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
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-27
75
Participants Needed
29
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of ICP-248 in adults with relapsed or refractory mantle cell lymphoma (MCL), a type of blood cancer. This phase 2, open-label study involves multiple centers and aims to assess how well ICP-248 works and its safety profile in patients who have not responded to previous treatments including anti-CD20 therapy and BTK inhibitors. Participants will receive ICP-248 orally according to the study protocol. This single-arm trial means all enrolled patients will be treated with ICP-248 without a comparison group. The study will monitor outcomes over a period of three years. During the study, participants will undergo regular assessments including scans to measure tumor response according to Lugano 2014 criteria, evaluations of overall response rate, complete response rate, disease control, duration and time to response, progression-free survival, and overall survival. Safety will be monitored by tracking adverse events. Quality of life questionnaires and blood tests for drug levels and minimal residual disease will also be conducted throughout the three-year follow-up period.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Histopathologically confirmed mantle cell lymphoma expressing Cyclin D1 and/or t(11;14) chromosomal translocation
- Relapsed or refractory mantle cell lymphoma with failure of at least one prior anti-CD20-containing therapy
- Failure of at least one prior BTK inhibitor-containing therapy
- Failure of the last line of therapy
- At least one measurable lesion according to Lugano 2014 criteria
- ECOG performance status of 0 to 2
You will not qualify if you...
- Blastoid or pleomorphic mantle cell lymphoma
- Current or prior history of central nervous system lymphoma
- Prior use of BCL-2 inhibitors such as venetoclax
- Autologous stem cell transplantation or cellular therapy within 3 months before first dose of ICP-248
- Prior allogeneic hematopoietic stem cell transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 years
Participants receive ICP-248 orally as per the protocol to treat relapsed or refractory mantle cell lymphoma.
Trial Site Locations
Total: 29 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100919
Actively Recruiting
3
West China Hospital of Sichuan University
Chengdu, Chengdu, China, 610041
Actively Recruiting
4
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400016
Actively Recruiting
5
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Actively Recruiting
6
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
7
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510050
Actively Recruiting
8
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Actively Recruiting
9
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530012
Actively Recruiting
10
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
11
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
12
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 451191
Actively Recruiting
13
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
14
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
15
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421001
Actively Recruiting
16
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210036
Actively Recruiting
17
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
18
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
19
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
20
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China, 250021
Actively Recruiting
21
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
22
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China, 266003
Actively Recruiting
23
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
24
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, China, 710004
Actively Recruiting
25
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Actively Recruiting
26
The Second People's Hospital of Yibin
Yibin, Sichuan, China, 644000
Actively Recruiting
27
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
28
The Affiliated Cancer Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, China, 830000
Actively Recruiting
29
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
A
Alexia Lu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here