A Single-arm, Multi-center, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of ICP-248 in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Status: Recruiting
Location: See all (29) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a single-arm, multi-center, open-label, phase 2 study to evaluate the efficacy and safety of ICP-248 in subjects with relapsed or refractory mantle cell lymphoma.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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 .

Locations
Other Locations
China
Peking University Third Hospital
RECRUITING
Beijing
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
NOT_YET_RECRUITING
Chongqing
Fujian Medical University Union Hospital
NOT_YET_RECRUITING
Fuzhou
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
The First Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
The First Affiliated Hospital of University of South China
NOT_YET_RECRUITING
Hengyang
Qilu Hospital of Shandong University
NOT_YET_RECRUITING
Jinan
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
Shandong Provincial Hospital Affiliated to Shandong First Medical University
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Guangxi Medical University Cancer Hospital
NOT_YET_RECRUITING
Nanning
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Fudan University Shanghai Cancer Center
NOT_YET_RECRUITING
Shanghai
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Tianjin
Union Hospital Tongji Medical College Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xian
The Affiliated Cancer Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Xinjiang
The Second People's Hospital of Yibin
NOT_YET_RECRUITING
Yibin
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Henan Provincial People's Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Alexia Lu
CO_HGRAC@innocarepharma.com
010-66609745
Time Frame
Start Date: 2025-08-21
Estimated Completion Date: 2028-07
Participants
Target number of participants: 68
Treatments
Experimental: ICP-248Tablets
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov

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