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New hope for tough lymphoma: experimental drug ICP-248 targets relapsed mantle cell cancer

NCT ID NCT07082686

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tests an experimental drug called ICP-248 in 75 adults whose mantle cell lymphoma has returned or stopped responding to prior therapy. The main goal is to see how many patients' tumors shrink or disappear. Researchers will also monitor side effects and how long any benefits last.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Started

Aug 2025

Expected to finish

Jul 2028

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: * ≥ 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 . Exclusion Criteria * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    29 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

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Fudan University Shanghai Cancer Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Guangxi Medical University Cancer Hospital

    RECRUITING

    Nanning, Guangxi, 530012, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450000, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410000, China

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

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210036, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100919, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    RECRUITING

    Jinan, Shandong, 250021, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510050, China

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Xinjiang, Xinjiang, 830000, China

  • The Affiliated Hospital of Qingdao University

    RECRUITING

    Qingdao, Shandong, 266003, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of University of South China

    RECRUITING

    Hengyang, Hunan, 421001, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 451191, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xian, Shanxi, 710004, China

  • The Second People's Hospital of Yibin

    RECRUITING

    Yibin, Sichuan, 644000, China

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

    RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Chengdu, 610041, China

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