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Relapsed/Refractory Marginal Zone Lymphoma (MZL)Phase 3NCT07896590

Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma

A Phase 3 study testing Orelabrutinib and ICP-248 in people with Relapsed/Refractory Marginal Zone Lymphoma (MZL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 46 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To evaluate the efficacy of olubrutinib combined with ICP-248 compared with the olubrutinib in the treatment of r/r MZL Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Orelabrutinib and ICP-248
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
46 sitesChina
Study dates
Oct 2026to Jan 2032
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

  • Aged ≥18 years, male or female.
  • Histopathologically confirmed marginal zone lymphoma (including splenic, nodal, extranodal MZL subtypes).
  • Has received at least one prior line of systemic therapy containing anti CD20 monoclonal antibody.
  • Disease is relapsed or refractory.
  • Has measurable disease per 2014 Lugano classification.
  • Meets required laboratory thresholds for hematological, liver, and renal function
Show all 9Show fewer
  • Females must have negative serum pregnancy test. Participants must use effective contraception during the study.
  • Able to comply with study procedures and assessments.
  • Voluntarily provides written informed consent.

Who cannot join

  • Confirmed transformation into an aggressive lymphoma.
  • Received anti cancer therapies within 2 weeks before first investigational product dose.
  • Chronic corticosteroid for anti cancer purpose during screening.
  • Any investigational agent within 4 weeks before study treatment; concurrent participation in other investigational therapeutic trials.
  • Prior disease refractory to BTK inhibitor or BCL 2 inhibitor treatment.
  • Prior allogeneic hematopoietic stem cell transplantation or CAR T therapy.
Show all 21Show fewer
  • central nervous system / meningeal lymphoma involvement.
  • Second primary malignancy within 2 years before screening.
  • Uncontrolled clinically significant cardiovascular disease.
  • Thromboembolic events within 6 months prior to first dose.
  • Grade 3 4 active bleeding within 2 months before screening or significant bleeding diathesis.
  • Clinically significant gastrointestinal malabsorption, major gastrointestinal resection.
  • Major surgery or severe trauma before first dose or planned selective surgery during study.
  • Active infection requiring intravenous anti infective therapy; positive HIV antibody; active HBV/HCV.
  • Severe interstitial lung disease, pneumoconiosis, radiation or drug induced pneumonitis.
  • Active autoimmune disease requiring systemic therapy.
  • Psychiatric/cognitive disorders.
  • Substance abuse.
  • Use of strong CYP3A/P gp inhibitors / inducers within 5 drug half lives before dosing or planned concomitant intake of strong modulating agents/food during study.
  • Received live / live attenuated vaccines within 4 weeks prior to first study drug dose.
  • Known severe hypersensitivity/anaphylaxis to investigational products, drug class agents or tablet excipients.

Trial locations and contacts

46 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jingnan Yang contact

(+86)-01066609990

CO-Clinicaltrial@innocarepharma.com

46 sites in 1 country

China46 sites

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Yuqin Song

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    Hongmei Jing, MD

  • Bozhou People's Hospital

    Bozhou, Anhui

    Hongfeng ge

  • The Second Xiangya Hospital, Central South University

    Changsha, Hunan, 410012

    Jin'an Ma

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

    Hui Zhou

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041

    Huangming Hong, 13570431657@163.com

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Liqun Zou

  • Xinqiao Hospital Army Medical University

    Chongqing, Chongqing Municipality, 400037

    Xixi Xiang

  • Southwest Hospital, Army Medical University

    Chongqing, Chongqing Municipality, 400038

    Shuangnian xu, dune_zhong@163.com

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

    Ting Yang, 408089668@qq.com

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

    HongMing He, 811481521@qq.com

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Qingqing Cai

  • The Second Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

    Min Dong

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

    Haiyan Yang, MD

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jie Jin

  • Harbin Medical University cancer hospital

    Harbin, Heilongjiang, 150081

    Lina zhao

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Jian Ge

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    fengbo jin, wzx2370@163.com

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Kaiyang Ding

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Hui Zeng

  • QiLu Hospital of Shandong University

    Jinan, Shandong, 250012

    Shuqian Xu

  • Shandong Cancer Hospital and Institute

    Jinan

    Zengjun Li

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

    Xiaopei Wang, cadillac570@163.com

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    Zijian Li

  • Liuzhou People's Hospital

    Liuzhou, Guangxi, 545006

    chunmei ban

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471000

    Xiaoqiang zhao

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Fei Li

  • Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University

    Nanjing, Jiangsu, 210000

    Jingyan Xu, xjy1967@sina.com

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

    Lei fan

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

    haiyan he

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

    Wenhao Zhang, gaoguangxun@fmmu.edu.cn

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110002

    Xiaojing Yan

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Lihong Liu, MD

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030013

    Liping Su

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300181

    Lihua Qiu

  • Tianjin First Central Hospital

    Tianjin

    Mingfeng Zhao

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830000

    Yan Li

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

    Jia Kui

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Liling Zhang

  • The first Affiliated Hospital Of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

    Pengcheng He

  • The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）

    Xi’an, Shanxi, 710004

    Wanhong Zhao

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

    Zhifeng Li

  • Xijing Hospital, Air Force Medical University

    Xian, Shanxi, 710032

    Guangxun Gao, gaoguangxun@fmmu.edu.cn

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

    Lei Zhang

  • Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

    Zhengzhou, Henan

    Keshu Zhou

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Zunmin Zhu

Other trials in China

About this study

Official title: A Randomized, Multicenter, Open Label Phase 3 Study to Evaluate Orelabrutinib Combined With ICP 248 Versus Orelabrutinib Monotherapy for Relapsed/Refractory Marginal Zone Lymphoma

To evaluate the efficacy of olubrutinib combined with ICP-248 compared with the olubrutinib in the treatment of r/r MZL

Read the detailed description

This is an open label, randomized, multicenter phase 3 study for adult participants with relapsed/refractory marginal zone lymphoma (R/R MZL). The main goals are to compare complete response rate (CRR) and progression free survival (PFS) between the two treatment groups assessed by an Independent Review Committee (IRC).

Being tested
Orelabrutinib, ICP-248
Medical subject headings
Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrelabrutinibDrug

    Participants receive orelabrutinib 150 mg oral once daily continuous dosing; each cycle is 28 days.

  • ICP-248Drug

    Eligible patients will receive ICP-248 orally as per the protocol

Study groups in NCT07896590
Study groupRoleWhat they receive
Orelabrutinib + ICP 248ExperimentalNot described
Receives: Drug: Orelabrutinib; Drug: ICP-248
OrelabrutinibActive comparatorNot described
Receives: Drug: Orelabrutinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR) assessed by Independent Review Committee (IRC)

    Measured: Approximately 3 years.

  2. Progression Free Survival (PFS) assessed by Independent Review Committee (IRC)

    Measured: Approximately 5 years.

Secondary outcomes (3)

  1. Objective Response Rate (ORR) and Overall Survival (OS)

    Measured: Approximately 5 years.

  2. Duration of response (DoR), time to response (TTR)

    Measured: Approximately 5 years.

  3. Safety endpoints include adverse events (AEs)

    Measured: Approximately 5 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionJan 2032 (estimated)

Resources

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
292 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896590
Sponsor's protocol ID
ICP-CL-00136
Status last verified
Oct 2026
First submitted
19 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orelabrutinib and ICP-248 in people with Relapsed/Refractory Marginal Zone Lymphoma (MZL), run by Beijing InnoCare Pharma Tech Co., Ltd. at 46 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 9 inclusion and 21 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 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 Jingnan Yang ((+86)-01066609990, CO-Clinicaltrial@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) assessed by Independent Review Committee (IRC) (time frame: Approximately 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07896590.

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 27 Oct 2026.

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