A Study of Rocbrutinib in Participants With Relapse or Refractory Mantle Cell Lymphoma

January 13, 2026 updated by: Guangzhou Lupeng Pharmaceutical Company LTD.

An Open Label, Single Arm, Multicenter Phase II Study of the Efficacy and Safety of Rocbrutinib Monotherapy for Recurrent or Refractory Mantle Cell Lymphoma

This is an open-label, single arm, multi-center Phase 2 study of oral Rocbrutinib in patients with mantle cell lymphoma who are failed or relapsed after remission or intolerated to Bruton's tyrosine kinase (BTK) inhibitor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Jun Zhu, MD, PhD
  • Phone Number: 86-010-88196596
  • Email: zj@bjcancer.org

Study Contact Backup

  • Name: Yuqin Song, MD, PhD

Study Locations

  • China
      • Baoding, China
        • Affiliated Hospital of Hebei University
      • Beijing, China
        • Beijing Friendship Hospital
      • Beijing, China
        • Beijing Boren Hospital
      • Changchun, China
        • The First Bethune Hospital of Jilin University
      • Chengdu, China
        • Sichuan Cancer Hospital
      • Foshan, China
        • The First People's Hospital of Foshan
      • Guangzhou, China
        • Nanfang Hospital, Southern Medical University
      • Guangzhou, China
        • Sun Yat-sen Memorial Hospital
      • Suzhou, China
        • The First Affiliated Hospital of Soochow University
      • Wenzhou, China
        • The First Affiliated Hospital of Wenzhou Medical University
      • Wuhan, China
        • Hubei Cancer Hospital
      • Wuhan, China
        • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, China
        • AnHui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100089
        • Peking University Third Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The first affiliated hospital of Chongqing mediacal university
    • Fujian
      • Fuzhou, Fujian, China
        • Fujian Medical University Union Hospital
      • Fuzhou, Fujian, China
        • Fujian Cancer Hospital
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Gansu
      • Lanzhou, Gansu, China
        • Gansu Provincial Cancer Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University Cancer Center
      • Meizhou, Guangdong, China
        • Meizhou people'shospital
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin First Hospital
    • Henan
      • Luoyang, Henan, China
        • The First Affiliated Hospital of Henan University of Science & Technology
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Liaoning
      • Dalian, Liaoning, China
        • The Second Hospital of Dalian Medical University
      • Shenyang, Liaoning, China
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China
        • Shandong Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • West China School of Medicine
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China
        • Tianjin Hematonosis Hospital
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rocbrutinib
Subjects who have previously received BTK inhibitors treatment failed or relapsed after remission or intolerated
Drug: Rocbrutinib
Subjects to take Rocbrutinib tablets orally with 240mL water, without food, Once daily.The treatment will continue until progressive disease, unacceptable toxicity, etc.
Other Names:
  • NWP-775
  • LP-168

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Up to 24 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of life (QoL)
Time Frame: Up to 24 Months
Quality of life Assessed By the European Organization for Research and Treatment of Cancer core quality of life (EORTC QLQ-C30) questionnaire (The total score ranges from 30 to126, Items 29 and 30 are scored from 1 to 7 points, and other items are scored from 1 to 4 points. Except for items 29 and 30, the higher value, the worse QoL.)
Up to 24 Months
Overall Response Rate
Time Frame: Up to 24 Months
To assess the anti-tumor activity of Rocbrutinib based on overall response rate (ORR) as assessed by investigator.
Up to 24 Months
Complete remission rate
Time Frame: Up to 24 Months
To assess the preliminary anti-tumor activity of Rocbrutinib based on complete remission rate (CR) as assessed by investigator and IRC.
Up to 24 Months
Progression Free Survival
Time Frame: Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.
To assess the preliminary anti-tumor activity of Rocbrutinib based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Measured from the date of first dose of study drug to the date of earliest disease progression or death or last visit, and assessed up to 24 months.
Overall survival
Time Frame: Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.
To assess the preliminary anti-tumor activity of Rocbrutinib based on Overall survival (OS) as assessed by investigator and IRC.
Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.
Duration of Response (DOR)
Time Frame: Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
To assess the preliminary anti-tumor activity of Rocbrutinib based on Duration of response (DOR) as assessed by the Investigator and IRC.
Measured from the date of the first remission to the date of earliest disease progression or death, and assessed up to 24 months.
Time to Response (TTR)
Time Frame: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
To assess the preliminary anti-tumor activity of Rocbrutinib based on Time to response (TTR) as assessed by the Investigator and IRC.
Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.
Safety Assessment
Time Frame: From first dose of study drug to 28 days after last dose of study drug
To evaluate the safety of Rocbrutinib by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0
From first dose of study drug to 28 days after last dose of study drug
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 24 hours post dose
Pharmacokinetics (PK) As Assessed By Maximum Observed Plasma Concentration (Cmax) Of Rocbrutinib
Up to 24 hours post dose
Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t)
Time Frame: Up to 24 hours post dose
PK As Assessed By Area Under The Plasma Concentration Time Curve From Time 0 To The Time Of The Last Quantifiable Concentration (AUC0-t) of Rocbrutinib
Up to 24 hours post dose
Maximum Observed Plasma Concentration (Tmax)
Time Frame: Up to 24 hours post dose
PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib
Up to 24 hours post dose
Half-life period (T1/2)
Time Frame: Up to 24 hours post dose
PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib
Up to 24 hours post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangzhou Lupeng Pharmaceutical Company LTD.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Jun Zhu, MD, PhD, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 5, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LP-168-CN201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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