Relapsed or Refractory Mantle Cell Lymphoma (MCL)Phase 3NCT07784101
A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).
A Phase 3 study testing ICP-248, Pirtobrutinib and Orelabrutinib in people with Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 24 sites in China.
Trial summary
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Mantle Cell Lymphoma (MCL)
- What is being tested?
- ICP-248, Pirtobrutinib and Orelabrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 24 sitesChina
- Study dates
- Oct 2026to Dec 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known intolerance to orelabrutinib or pirtobrutinib treatment.
- Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
- Patients with other malignancies within 2 years prior to enrollment.
- Uncontrolled or significant cardiovascular disease.
- Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
- Participants with severe central nervous system diseases.
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- Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
- Underwent major surgery within 4 weeks prior to the first dose.
- Active infections require systemic treatment.
- Active autoimmune diseases.
- Known central nervous system lymphoma.
- Known alcohol or drug dependence.
Who cannot join
- Known intolerance to orelabrutinib or pirtobrutinib treatment.
- Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past.
- Patients with other malignancies within 2 years prior to enrollment.
- Uncontrolled or significant cardiovascular disease.
- Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding.
- Participants with severe central nervous system diseases.
Show all 12Show fewer
- Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy.
- Underwent major surgery within 4 weeks prior to the first dose.
- Active infections require systemic treatment.
- Active autoimmune diseases.
- Known central nervous system lymphoma.
- Known alcohol or drug dependence.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites
Peking University Third Hospital
Beijing, Beijing Municipality, 100083
Hongmei Jing, bysyjhm@sina.com
Hunan Cancer Hospital
Changsha, Hunan, 410000
Hui Zhou, zhouhui@hnca.org.cn
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Huangming Hong, 13570431657@163.com
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Jie Wang, 42922155@qq.com
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Yingyu Nan, nanxi221@sina.com
Xinqiao Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
Xi Zhang, zhangxxi@sina.com
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
HongMing He, 811481521@qq.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 636799
He Huang, huanghe@sysucc.org.cn
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jie Jin, jiej0503@163.com
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Haiyan Yang, haiyanyang1125@163.com
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Jian Ge, gejian52@163.com
Shandong Cancer Hospital
Jinan, Shandong, 250117
Zengjun Li, zengjunli@163.com
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Xiaopei Wang, cadillac570@163.com
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, Jiangsu, 210000
Jingyan Xu, xjy1967@sina.com
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Wenhao Zhang, gaoguangxun@fmmu.edu.cn
The first Hospital of China Medical University
Shenyang, Liaoning, 110801
Xiaojing Yan, yanxiaojing_pp@hotmail.com
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Lihong Liu, 13831177920@163.com
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052
Shuhua Yi, yishuhua@ihcams.ac.cn
Lugui Qiu
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Wei Jia, jiawei_tongji@163.com
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital
Wuhan, Hubei, 430030
Jun Fang, fangjunth@126.com
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, 710004
Wanhong Zhao, 13991365406@163.com
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)
Xian, Shanxi, 710032
Guangxun Gao, gaoguangxun@fmmu.edu.cn
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Keshu Zhou, gcpzks@163.com
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zunmin Zhu, zhuzm1964@163.com
About this study
Official title: A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)
This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).
- Being tested
- ICP-248, Pirtobrutinib, Orelabrutinib
- Medical subject headings
- Recurrence, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-248Drug
Administered orally
PirtobrutinibDrug
Administered orally
OrelabrutinibDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| ICP-248 in combination with Orelabrutinib | Experimental | Not described Receives: Drug: ICP-248; Drug: Orelabrutinib |
| Pirtobrutinib | Active comparator | Not described Receives: Drug: Pirtobrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
Measured: 6 years
Secondary outcomes (8)
Investigator-assessed PFS according to Lugano 2014.
Measured: 6 years
IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014
Measured: 6 years
IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014
Measured: 6 years
IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014
Measured: 6 years
IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014
Measured: 6 years
Time to next treatment (TTNT)
Measured: 6 years
Overall Survival (OS)
Measured: 6 years
Eastern Cooperative Oncology Group (ECOG) performance status
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2032 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784101
- Sponsor's protocol ID
- ICP-CL-01209
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No