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New combo therapy aims to control blood cancer without a cure

NCT ID NCT06378138

Disease control Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug combination (ICP-248 plus orelabrutinib) in people with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. The goal is to see if the combination is safe and tolerable. About 226 adults aged 18 to 80 with measurable disease and a need for treatment will participate. This is not a cure; it aims to control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 226 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic malignancies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    53 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anhui Provincial Hospital (The First Affiliated Hospital of University of Science and Technology of China)

    RECRUITING

    Hefei, Anhui, 230001, China

  • Bethune First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, 130061, China

  • Blood Diseases Hospital of Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Changzhou First People's Hospital

    NOT_YET_RECRUITING

    Changzhou, Jiangsu, 213003, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Gansu Provincial People's Hospital

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Guangdong General Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510080, China

  • Henan Cancer Hospital

    RECRUITING

    Zhenzhou, Henan, 450003, China

  • Henan Provincial People's Hospital

    RECRUITING

    Zhengzhou, Henan, 463599, China

  • Huai'an First People's Hospital

    RECRUITING

    Huai'an, Jiangsu, 223300, China

  • Huashan Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410031, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jining First People's Hospital

    RECRUITING

    Jining, Shandong, 272011, China

  • Linyi City Cancer Hospital

    RECRUITING

    Linyi, Shandong, 276002, China

  • Nanfang Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510515, China

  • Nanyang City Center Hospital

    RECRUITING

    Nanyang, Henan, 473005, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Shaanxi Provincial People's Hospital

    RECRUITING

    Xi’an, Shanxi, 710068, China

  • Shandong Cancer Hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shandong Provincial Hospital

    RECRUITING

    Jinan, Shandong, 250021, China

  • Shanghai Huashan Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 201108, China

  • Shanxi Cancer Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030013, China

  • Shengjing Hospital affiliated to China Medical University

    RECRUITING

    Shenyang, Liaoning, Liaoning, China

  • Sichuan Provincial People's Hospital

    RECRUITING

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510055, China

  • The Affiliated Cancer Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

  • The Affiliated Hospital of North China University of Science and Technology

    RECRUITING

    Tangshan, Hebei, 063000, China

  • The Affiliated Hospital of Zunyi Medical University

    NOT_YET_RECRUITING

    Zunyi, Guizhou, 563003, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Affiliated Hospital of Bengbu Medical College

    RECRUITING

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Guangxi Medical University

    NOT_YET_RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Kunming Medical University

    RECRUITING

    Kunming, Yunnan, 650032, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050010, China

  • The People's Hospital Affiliated to Ningbo University

    RECRUITING

    Ningbo, Zhejiang, 315040, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, 710004, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116023, China

  • The Second Hospital of Shanxi Medical University

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030001, China

  • The Second Xiangya Hospital, Central South University

    RECRUITING

    Changsha, Hunan, 410012, China

  • Tianjin Medical University Cancer Institute and Hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300181, China

  • Tianjin People's Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300120, China

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430011, China

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Xinqiao Hospital, the Second Affiliated Hospital of Army Military Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400037, China

  • Yibin Second People's Hospital

    RECRUITING

    Yibin, Sichuan, 644002, China

  • Yichang Central People's Hospital

    RECRUITING

    Yichang, Hubei, 443003, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.