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
- Are there results?
- Not yet: the study is under way
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.
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.
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.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07784101
- Acronym / sponsor ID
- ICP-CL-01209
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2032 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-248 in combination with Orelabrutinib | Experimental | Drug: ICP-248, Drug: Orelabrutinib |
| Pirtobrutinib | Active comparator | Drug: Pirtobrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICP-248Administered orally | Drug | ICP-248 in combination with Orelabrutinib |
| PirtobrutinibAdministered orally | Drug | Pirtobrutinib |
| OrelabrutinibAdministered orally | Drug | ICP-248 in combination with Orelabrutinib |
Primary outcome
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
Time frame: 6 years
8 secondary outcomes
Investigator-assessed PFS according to Lugano 2014.
Time frame: 6 years
IRC-assessed and investigators-assessed overall response rate (ORR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed complete response rate (CRR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed duration of response (DOR) according to Lugano 2014
Time frame: 6 years
IRC-assessed and investigators-assessed time to first response (TTR) according to Lugano 2014
Time frame: 6 years
Time to next treatment (TTNT)
Time frame: 6 years
Overall Survival (OS)
Time frame: 6 years
Eastern Cooperative Oncology Group (ECOG) performance status
Time frame: 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexia Lu (010-66609745, CO_HGRAC@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) as assessed by Independent Review Committee (IRC). (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.