Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can a Two-Drug combo outsmart a tough blood cancer?

NCT ID NCT07784101

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether combining two oral drugs—ICP-248 and orelabrutinib—works better than the current drug pirtobrutinib alone for people with mantle cell lymphoma that has returned or stopped responding to treatment. About 280 participants will be randomly assigned to one of the two treatment groups. The main goal is to see how long the cancer stays under control, and the study will also track side effects and response rates.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICP-248 in combination with orelabrutinib, compared against pirtobrutinib
What this could lead to
If the combination works better than pirtobrutinib alone, it could offer a new, more effective treatment option for people with mantle cell lymphoma that has returned or stopped responding to therapy.
What could go wrong
This is an early-stage comparison in a specific patient group, and the combination may not prove more effective or may cause additional side effects. Results from this trial will need confirmation before any new treatment becomes available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. 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. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. 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. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence. Exclusion Criteria: 1. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. 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. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. 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. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Relapsed or refractory mantle cell lymphoma (MCL) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

mantle cell lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory mantle cell lymphoma (MCL)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003, China

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

    Wuhan, Hubei, 430030, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410000, China

  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300052, China

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

    Nanjing, Jiangsu, 210000, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083, China

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117, China

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610041, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 636799, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000, China

  • The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital)

    Xian, Shanxi, 710032, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xian, Shanxi, 710004, China

  • The first Hospital of China Medical University

    Shenyang, Liaoning, 110801, China

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

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041, China

  • Xinqiao Hospital of Army Medical University

    Chongqing, Chongqing Municipality, 400037, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.