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

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: Active, not recruiting
• Conditions: Mantle Cell Lymphoma (MCL)
• Intervention / Treatment: Drug: Rocbrutinib

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Overall Response Rate	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

Outcome Measure	Measure Description	Time Frame
Quality of life (QoL)	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	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	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	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	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)	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)	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	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)	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)	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)	PK As Assessed By Time To Maximum Observed Plasma Concentration (Tmax) Of Rocbrutinib	Up to 24 hours post dose
Half-life period (T1/2)	PK As Assessed By Time To Half-life period (T1/2) Of Rocbrutinib	Up to 24 hours post dose

Collaborators and Investigators

• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.
• Investigators: Study Chair: Jun Zhu, MD, PhD, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Actual): December 5, 2024
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Mantle-Cell
• Other Study ID 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