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Clinical Trials in China / NCT07784101
Starting soon Phase 3

A Phase 3 Study to Compare the Efficacy of ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL).

NCT07784101 · tracked via the Priya Life Science China tracker
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Phase
Phase 3
Started
2026-10
Last updated
2026-08-25

Condition(s) studied

Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Investigational drug(s) / intervention(s)

ICP-248 →Pirtobrutinib →Orelabrutinib →

ICP-248: Administered orally

Pirtobrutinib: Administered orally

Orelabrutinib: Administered orally

Study summary

This study aims to compare the efficacy and safety of ICP-248 in combination with orelabrutinib versus pirtobrutinib in patients with relapsed or refractory mantle cell lymphoma (r/r MCL).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence. Exclusion Criteria: 1. Known intolerance to orelabrutinib or pirtobrutinib treatment. 2. Received autologous hematopoietic stem cell transplantation (ASCT) or cell therapy within 3 months prior to the first dose of the investigational product. Received allogeneic hematopoietic stem cell transplantation at any time in the past. 3. Patients with other malignancies within 2 years prior to enrollment. 4. Uncontrolled or significant cardiovascular disease. 5. Hemophilia A, Hemophilia B, von Willebrand disease history or requiring the use of warfarin or equivalent vitamin K antagonist anticoagulants (such as phenprocoumon, etc.) or assessed by the investigator to have a tendency for spontaneous bleeding. 6. Participants with severe central nervous system diseases. 7. Participants with significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption, or those who have undergone total gastrectomy. 8. Underwent major surgery within 4 weeks prior to the first dose. 9. Active infections require systemic treatment. 10. Active autoimmune diseases. 11. Known central nervous system lymphoma. 12. Known alcohol or drug dependence.

Primary outcome measure(s)

Trial sites (24)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
Xinqiao Hospital of Army Medical University Chongqing Chongqing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Sun Yat-sen University Cancer Center Guangzhou Guangdong
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei
Henan Cancer Hospital Zhengzhou Henan
Henan Provincial People's Hospital Zhengzhou Henan
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital Wuhan Hubei
Hunan Cancer Hospital Changsha Hunan
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University Nanjing Jiangsu
The first Hospital of China Medical University Shenyang Liaoning
Shandong Cancer Hospital Jinan Shandong
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
The Second Affiliated Hospital of Xi'an Jiaotong University Xian Shanxi
The First Affiliated Hospital of the PLA Air Force Military Medical University (Xijing Hospital) Xian Shanxi
Sichuan Cancer Hospital Chengdu Sichuan
West China Hospital of Sichuan University Chengdu Sichuan
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences Tianjin Tianjin Municipality
Yunnan Cancer Hospital Kunming Yunnan
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
Zhejiang Cancer Hospital Hangzhou Zhejiang

More Beijing InnoCare Pharma Tech Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07784101 on ClinicalTrials.gov ↗ ← All trials in China