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Clinical Trials in China / NCT06378138
Recruiting Phase 2/3

ICP-248 in Combination With Orelabrutinib in Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (APEX-03)

NCT06378138 · tracked via the Priya Life Science China tracker
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Phase
Phase 2/3
Started
2024-05-15
Last updated
2025-11-21

Condition(s) studied

Hematologic Malignancies

Investigational drug(s) / intervention(s)

ICP-248Orelabrutinib

ICP-248: Eligible patients will receive ICP-248 orally as per the protocol,once daily for every 28 days as one treatment cycle

Orelabrutinib: Eligible patients will receive Orelabrutinib orally as per the protocol,once daily for every 28 days as one treatment cycle

Study summary

Evaluate the safety, tolerability and pharmacokinetics of ICP-248 in Combination with Orelabrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 and ≤ 80 years. 2. CLL/SLL is diagnosed by histopathology and/or flow cytometry according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL 2018): 3. Having an indication for treatment that meets the criteria for iwCLL 2018 4. Subjects must have measurable lesion according to the Lugano 2014 Assessment Criteria. 5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months. 6. Adequate hematologic function 7. Patients with basically normal coagulation function 8. Patients with adequate hepatic, renal, pulmonary and cardiac functions 9. Subjects are able to communicate with the investigator well and to complete the study as specified in the study. 10. Before the trial, the subjects shall understand the nature, significance, possible benefits, inconveniences and potential risks, as well as the study procedures of the trial in detail and voluntarily sign the written Informed Consent Form (ICF). Exclusion Criteria: 1. Central nervous system involvement. 2. Concomitant Richter transformation. 3. Prior systemic treatment, excluding emergency pretreatment to reduce white blood cells and relieve leukostasis. 4. Requireing continuous glucocorticoid support or glucocorticoid therapy within 5 days. 5. History of allogeneic stem cell transplantation. 6. Major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational drug or require elective surgery during the trial. 7. Presence of active infection that requires intravenous anti-infective therapy. 8. Hepatitis B or C virus infection. 9. History of immunodeficiency disease or Significant cardiovascular disease 10. Central nervous system disorders or Severe bleeding disorder 11. Alcohol or drug dependence. 12. Mental disorders or poor compliance.

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui Recruiting
Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China) Hefei Anhui Recruiting
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University Chongqing Chongqing Municipality Recruiting
Fujian Medical University Union Hospital Fuzhou Fujian Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Gansu Provincial People's Hospital Lanzhou Gansu Recruiting
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Guangdong General Hospital Guangzhou Guangdong Not Yet Recruiting
Nanfang Hospital of Southern Medical University Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The Affiliated Hospital of Zunyi Medical University Zunyi Guizhou Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
The Affiliated Hospital of North China University of Science and Technology Tangshan Hebei Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Nanyang City Center Hospital Nanyang Henan Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Recruiting
Henan Cancer Hospital Zhenzhou Henan Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Union Hospital Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Yichang Central People's Hospital Yichang Hubei Recruiting
The Second Xiangya Hospital, Central South University Changsha Hunan Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting
Changzhou First People's Hospital Changzhou Jiangsu Not Yet Recruiting
Huai'an First People's Hospital Huai'an Jiangsu Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
Bethune First Hospital of Jilin University Changchun Jilin Recruiting
The Second Hospital of Dalian Medical University Dalian Liaoning Recruiting
Shengjing Hospital affiliated to China Medical University Shenyang Liaoning Recruiting
Qilu Hospital of Shandong University Jinan Shandong Recruiting
Shandong Provincial Hospital Jinan Shandong Recruiting
Shandong Cancer Hospital Jinan Shandong Recruiting
Jining First People's Hospital Jining Shandong Recruiting
Linyi City Cancer Hospital Linyi Shandong Recruiting
Huashan Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Huashan Hospital Shanghai Shanghai Municipality Not Yet Recruiting
The Second Hospital of Shanxi Medical University Taiyuan Shanxi Not Yet Recruiting

+ 13 more sites — see the full list on the official registry below.

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 NCT06378138 on ClinicalTrials.gov ↗ ← All trials in China