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New pill shows promise for tough blood cancer

NCT ID NCT05716087

Disease control Sponsor: Guangzhou Lupeng Pharmaceutical Company 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests an oral drug called rocbrutinib in 62 people with mantle cell lymphoma that has come back or not responded to other treatments. Participants take the drug once daily until their disease worsens or side effects become too severe. The main goal is to see how many patients have their tumors shrink or disappear.

What this could mean

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

Active substance
rocbrutinib (also called NWP-775 or LP-168), an oral drug
What this could lead to
If it works, this could offer a new treatment option for people with mantle cell lymphoma who have not responded to other therapies.
What could go wrong
This is a small, early-phase trial with only 62 participants and no comparison group. The drug may not work for everyone and could cause side effects.

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 62 people

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

Started

Feb 2023

Expected to finish

Jun 2026

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. Per 2017 revised WHO lymphoma classification criteria, subject must have diagnosed with MCL. 2. At least one measurable lesion. 3. Subjects who have previously received the treatment regimen containing anti-CD20 and at least one BTKi treatment failed or relapsed after remission or intolerated; Or Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated, and are not suitable for treatment with anti-CD20. 4. ECOG≤2. 5. Adequate hematologic function. 6. Adequate hepatic and renal function. 7. Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal \[and 2 years of non-therapy-induced amenorrhea\] or surgically sterile) to observe conventional and effective birth control. Exclusion Criteria: 1. Received non-covalent BTK inhibitor treatment. 2. Subjects who have received the following treatments within 4 weeks or 5 half-lives before the first dose of Rocbrutinib: Antitumor therapies including myelosuppressive chemotherapy, targeted therapy, biological therapy and/or immunotherapy; Any investigational treatment; Patients who have undergone major surgery, severe trauma or radiotherapy. 3. Subjects who have received the following treatments within 2 weeks before the first dose of Rocbrutinib: Steroids or traditional herbal medicine for antitumor purposes; Strong and moderate CYP3A inhibitors and inducers; All drugs that may cause QTc interval prolongation or torsional tachycardia. 4. Disease states where clinical manifestations may be difficult to control, including HIV, HBV, HCV, syphilis positive or active bacterial and fungal infections. 5. Disease affects the central nervous system. 6. Any gastrointestinal conditions that may severely affect the study drug absorption or pharmacokinetic parameters.

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Conditions

The condition(s) this trial relates to.

mantle cell lymphoma

As listed by the trial registrant

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

Mantle cell lymphoma (MCL)

Contacts and locations

Locations

  • Affiliated hospital of hebei university

    Baoding, China

  • Anhui provincial cancer hospital

    Hefei, Anhui, China

  • Beijing Boren Hospital

    Beijing, China

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142, China

  • Beijing Friendship hospital

    Beijing, China

  • Fujian Cancer Hospital

    Fuzhou, Fujian, China

  • Fujian Medical university union hospital

    Fuzhou, Fujian, China

  • Gansu provincial cancer hospital

    Lanzhou, Gansu, China

  • Harbin First Hospital

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, China

  • Henan provincial people's hospital

    Zhengzhou, Henan, China

  • Hubei Cancer Hospital

    Wuhan, China

  • Hunan cancer hospital

    Changsha, Hunan, China

  • Jiangsu cancer hospital

    Nanjing, Jiangsu, China

  • Jiangsu province hospital

    Nanjing, Jiangsu, China

  • Meizhou people'shospital

    Meizhou, Guangdong, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, China

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100089, China

  • Qilu hospital of Shandong university

    Jinan, Shandong, China

  • Shandong Cancer Hospital

    Jinan, Shandong, China

  • Shengjing hospital of China medical university

    Shenyang, Liaoning, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • Sun Yat-sen Memorial Hospital

    Guangzhou, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

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

    Luoyang, Henan, China

  • The First Affiliated Hospital of Soochow University

    Suzhou, China

  • The First Bethune Hospital of Jilin University

    Changchun, China

  • The First People's Hospital of Foshan

    Foshan, China

  • The first affiliated hospital of Anhui medical university

    Hefei, Anhui, China

  • The first affiliated hospital of Chongqing mediacal university

    Chongqing, Chongqing Municipality, China

  • The first affiliated hospital of Nanchang university

    Nanchang, Jiangxi, China

  • The first affiliated hospital of Wenzhou medical university

    Wenzhou, China

  • The first affiliated hospital of Xiamen university

    Xiamen, Fujian, China

  • The first affiliated hospital of Zhengzhou university

    Zhengzhou, Henan, China

  • The first hospital of China medical university

    Shenyang, Liaoning, China

  • The fourth hospital of Hebei medical university

    Shijiazhuang, Hebei, China

  • The second hospital of dalian medical university

    Dalian, Liaoning, China

  • Tianjin Hematonosis Hospital

    Tianjin, Tianjin Municipality, China

  • Tianjin medical university cancer hospital

    Tianjin, Tianjin Municipality, China

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

    Wuhan, China

  • West China School of Medicine

    Chengdu, Sichuan, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

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