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

November 18, 2025 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

A Phase II/III Study of ICP-248 in Combination With Orelabrutinib in Patients With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
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.
226

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
  • Phase 3

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.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • the First Affiliated Hospital of Bengbu Medical College
        • Contact:
          • Yanli Yang
      • Hefei, Anhui, China, 230022
        • Recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
          • Jian Ge
      • Hefei, Anhui, China, 230001
        • Recruiting
        • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)
        • Contact:
          • Xingbing Wang
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Xiaoqiong Tang
      • Chongqing, Chongqing Municipality, China, 400037
        • Recruiting
        • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University
        • Contact:
          • Xixi Xiang
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Zhenshu Xu
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Bing Xu
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial People's Hospital
        • Contact:
          • Qike Zhang
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Not yet recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Xutao Guo
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
          • Wenyu Li
      • Guangzhou, Guangdong, China, 510055
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
          • Yang Liang
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
          • Jun Luo
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Not yet recruiting
        • The Affiliated Hospital of Zunyi Medical University
        • Contact:
          • Mingqiang Ren
    • Hebei
      • Shijiazhuang, Hebei, China, 050010
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Lihong Liu
      • Tangshan, Hebei, China, 063000
        • Recruiting
        • The Affiliated Hospital of North China University of Science and Technology
        • Contact:
          • Zhenyu 063000 Yan
    • Henan
      • Luoyang, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Ling Qin
      • Nanyang, Henan, China, 473005
        • Recruiting
        • Nanyang City Center Hospital
        • Contact:
          • Chao Li
      • Zhengzhou, Henan, China, 463599
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
          • zunmin Zhu
      • Zhenzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College， Huazhong University of Science and Technology
        • Contact:
          • Guohui Cui
      • Wuhan, Hubei, China, 430011
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Xiaoxi Zhou
      • Yichang, Hubei, China, 443003
        • Recruiting
        • Yichang Central People's Hospital
        • Contact:
          • Huili Cai
    • Hunan
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Fang Zhou
      • Changsha, Hunan, China, 410012
        • Recruiting
        • The Second Xiangya Hospital, Central South University
        • Contact:
          • Hongling Peng
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Not yet recruiting
        • Changzhou First People's Hospital
        • Contact:
          • weiying gu
      • Huai'an, Jiangsu, China, 223300
        • Recruiting
        • Huai'an first people's hospital
        • Contact:
          • Chunling Wang
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Wei Xu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Fei Li
    • Jilin
      • Changchun, Jilin, China, 130061
        • Recruiting
        • Bethune First Hospital of Jilin University
        • Contact:
          • Ou Bai
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
          • Xiuhua Sun
      • Shenyang, Liaoning, China, Liaoning
        • Recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
          • Aijun Liao
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
          • Ming Hou
      • Jinan, Shandong, China, 250021
        • Recruiting
        • Shandong Provincial Hospital
        • Contact:
          • Xiaosheng Fang
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Shandong Cancer Hospital
        • Contact:
          • Ji Ma
      • Jining, Shandong, China, 272011
        • Recruiting
        • Jining First People's Hospital
        • Contact:
          • Tongfeng Zhao
      • Linyi, Shandong, China, 276002
        • Recruiting
        • Linyi City Cancer Hospital
        • Contact:
          • Meifang Zheng
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200040
        • Recruiting
        • Huashan Hospital
        • Contact:
          • Yan Yuan
      • Shanghai, Shanghai Municipality, China, 201108
        • Not yet recruiting
        • Shanghai Huashan Hospital
        • Contact:
          • Yan Yuan
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • The Second Hospital of Shanxi Medical University
        • Contact:
          • Zhuanzhen Zheng
      • Taiyuan, Shanxi, China, 030013
        • Not yet recruiting
        • Shanxi Cancer Hospital
        • Contact:
          • Liping Su
      • Xi’an, Shanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
          • yi wang
      • Xi’an, Shanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • Jianli Wang
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • Kai Shen
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
          • xiaobing huang
      • Yibin, Sichuan, China, 644002
        • Recruiting
        • Yibin Second People's Hospital
        • Contact:
          • shihua huang
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Blood Diseases Hospital of Chinese Academy of Medical Sciences
        • Contact:
          • Tingyu Wang
      • Tianjin, Tianjin Municipality, China, 300120
        • Not yet recruiting
        • Tianjin People's Hospital
        • Contact:
          • xingli Zhao
      • Tianjin, Tianjin Municipality, China, 300181
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital
        • Contact:
          • Lihua Qiu
    • Xinjiang Uygur Autonomous Region
      • Ürümqi, Xinjiang Uygur Autonomous Region, China, 830000
        • Recruiting
        • The Affiliated Cancer Hospital of Xinjiang Medical university
        • Contact:
          • Shujuan Wen
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
          • Mingxia Shi
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital of Zhejiang University school of medicine
        • Contact:
          • Wenjuan Yu
      • Ningbo, Zhejiang, China, 315040
        • Recruiting
        • The People's Hospital Affiliated to Ningbo University
        • Contact:
          • Ying Lu

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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

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
Time Frame
Adverse events (AEs) and serious adverse events (SAEs) evaluation according to CTCAE V5.0 or iwCLL 2018 criteria
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in pulse.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in blood pressure.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in ECG QRS interval.
Time Frame: Up to 6 years
Up to 6 years
Changes from baseline in ECG QT interval.
Time Frame: Up to 6 years
Up to 6 years

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.
Beijing InnoCare Pharma Tech Co., Ltd.

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.
May 15, 2024

Primary Completion (Estimated)

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.
November 25, 2030

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.
July 25, 2031

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).
April 6, 2024

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.
April 17, 2024

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.
April 22, 2024

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.
November 21, 2025

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.
November 18, 2025

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.
October 1, 2025

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.
  • ICP-CL-01203

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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