Relapsed or Refractory Mantle Cell Lymphoma (MCL)Phase 2NCT07082686
A Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma (APEX-06)
A Phase 2 study testing ICP-248 in people with Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 29 sites in China.
Trial 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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 29 sitesChina
- Study dates
- 21 Aug 2025to Jul 2028
- Phase
- Phase 2
- 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
- ≥ 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 .
Who cannot join
- 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.
Trial locations and contacts
29 sites in 1 country. Contact the study team or a site near you to ask about taking part.
29 sites in 1 country
China29 sites, 29 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100919
Hongmei Jing, 010-82267893, bysyjhm@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Ou Bai, 0431-88782222, lbl2054@163.com
- Recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Hui Zhou, 0731-88651900, zhouhui9403@126.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Chengdu, 610041
Liqun Zou, 028-85422114, hxlcyxy@163.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Xiaodong Wang, 028-87393999, WXD621025@163.com
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Li Wang, 023-68811360, liwangls@yahoo.com
- Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Qiying Li, 023-65301682, 349331690@qq.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Jianzhen Shen, 0591-83357896, Doctorsjz@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510050
Zhiming Li, 020-87343560, lizhm@sysucc.org.cn
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Wenyu Li, 020-83827812, gcpliwy@126.com
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jie Jin, 0571-87236114, JIEJ0503@163.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022
Jian Ge, 0551-62922800, Gejian52@163.com
- Recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421001
Zeyu Luo, 0734-8279467, luozeyu0827@sina.com
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Jingjing Ye, 0531-82168888, yejingjing@sdu.edu.cn
- Recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, 250021
Xiaosheng Fang, 0531-87938911, fxsh_1010@126.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Zengjun Li, 0531-87984777, zengjunli@163.com
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Fei Li, 0791-88603000, lifeigcp2022@163.com
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210036
Li Wang, lilyw7878@163.com
- Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530012
Zhe Li, 0771-5331955, li_zhe811@163.com
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003
Xia Zhao, 0532-82911847, zhaoxia@qdu.edc.cn
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Qunling Zhang, 021-6417 5590, zqldoc@163.com
- Recruiting
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Rui Lv, 022-23909083, Lvrui.ok2@163.com
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Jun Fang, 027-85726114, fangjuntj@126.com
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xian, Shanxi, 710004
Wanhong Zhao, 029-87679000, 13991365406@163.com
- Recruiting
The Affiliated Cancer Hospital of Xinjiang Medical University
Xinjiang, Xinjiang, 830000
Shujuan Wen, 0991-7968027, 736587502@qq.com
- Recruiting
The Second People's Hospital of Yibin
Yibin, Sichuan, 644000
Shihua Huang, 0831-8886606, 2327208752@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Keshu Zhou, 4000371818, dr_zkshu23810@163.com
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Zunmin Zhu, 0371-96195, zhuzm1964@163.com
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 451191
Xudong Zhang, 0371-67966263, feverxxd@126.com
About this study
Official title: 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
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.
- Being tested
- ICP-248
- 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
Eligible patients will receive ICP-248 orally as per the protocol
| Study group | Role | What they receive |
|---|---|---|
| ICP-248Tablets | Experimental | Not described Receives: Drug: ICP-248 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
Measured: 3 years
Secondary outcomes (15)
According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)
Measured: 3 years
Investigator-assessed ORR
Measured: 3 years
According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).
Measured: 3 years
According to Lugano 2014: IRC and investigator assessed duration of response (DOR).
Measured: 3 years
According to Lugano 2014: IRC and investigator assessed time to initial response (TTR).
Measured: 3 years
According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) .
Measured: 3 years
Overall survival (OS)
Measured: 3 years
Adverse event (AE) assessed according to CTCAE v5.0 criteria
Measured: 3 years
Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L).
Measured: 3 years
Area under the plasma concentration versus time curve (AUC)
Measured: 3 years
minimal residual disease （MRD） status
Measured: 3 years
Peak Plasma Concentration (Cmax)
Measured: 3 years
Time of maximum observed plasma(Tmax)
Measured: 3 years
Trough concentration(Ctrough)
Measured: 3 years
Apparent clearance (CL/F)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start21 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionJul 2028 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT07082686
- Sponsor's protocol ID
- ICP-CL-01206
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2025
- Last updated
- 23 Jul 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07082686
- Acronym / sponsor ID
- ICP-CL-01206
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 24 Jul 2025 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICP-248Tablets | Experimental | Drug: ICP-248 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 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 the last line of therapy.
- At least one measurable lesion according to the Lugano 2014 criteria,.
Key exclusion criteria (4 listed)
- 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.
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-248Eligible patients will receive ICP-248 orally as per the protocol | Drug | ICP-248Tablets |
Primary outcome
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC)
Time frame: 3 years
15 secondary outcomes
According to Lugano 2014: IRC and investigator assessed complete response rate (CRR)
Time frame: 3 years
Investigator-assessed ORR
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed disease control rate (DCR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed duration of response (DOR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed time to initial response (TTR).
Time frame: 3 years
According to Lugano 2014: IRC and investigator assessed progression-free survival (PFS) .
Time frame: 3 years
Overall survival (OS)
Time frame: 3 years
Adverse event (AE) assessed according to CTCAE v5.0 criteria
Time frame: 3 years
Functional Assessment Of Cancer Therapy-Lymphoma (Fact-Lym) and European Quality Of Life Five Dimension Five Level Scale Questionnaire (Eq-5D-5L).
Time frame: 3 years
Area under the plasma concentration versus time curve (AUC)
Time frame: 3 years
minimal residual disease （MRD） status
Time frame: 3 years
Peak Plasma Concentration (Cmax)
Time frame: 3 years
Time of maximum observed plasma(Tmax)
Time frame: 3 years
Trough concentration(Ctrough)
Time frame: 3 years
Apparent clearance (CL/F)
Time frame: 3 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 23 Jul 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.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICP-248 in people with Relapsed or Refractory Mantle Cell Lymphoma (MCL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 29 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Overall response rate (ORR) according to Lugano 2014 assessed by the independent review committee (IRC) (time frame: 3 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 23 Jul 2026.