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New pill shows promise against blood cancers in early trial

NCT ID NCT05728658

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage study tests an experimental drug called ICP-248, taken as a pill, for people with certain blood cancers (like leukemia or lymphoma). The drug is given alone or with another drug, orelabrutinib. The main goals are to check safety, find the right dose, and see if it shrinks tumors. About 191 adults aged 18 to 80 are being enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ICP-248 (an experimental oral drug) alone or combined with orelabrutinib
What this could lead to
If successful, this could point toward a new treatment option for certain blood cancers like leukemia or lymphoma.
What could go wrong
This is an early Phase 1 trial, so safety and proper dosing are the main focus—not yet proof of effectiveness. Side effects or lack of benefit are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 191 people

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

Started

Mar 2023

Expected to finish

Oct 2026

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. One of the following histopathologically and/or flow cytometry-confirmed diseases according to the 2016 World Health Organization (WHO) classification criteria for lymphohematopoietic neoplasms or meeting the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria: Histopathologically and/or flow cytometry-confirmed CLL/SLL; Pathologically confirmed MCL; Pathologically confirmed B-NHL, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), and lymphoplasmacytic lymphoma (LPL). 3. Relapsed disease or refractory disease 4. For subjects with B-NHL: Patients must have measurable diseasePatients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 2 and a life expectancy of ≥ 6 months. 5. Adequate hematologic function. 6. Patients with basically normal coagulation function. 7. Patients with adequate hepatic, renal, pulmonary and cardiac functions. 8. CLL/SLL Patients with an absolute lymphocyte count ≥ 50 x 109/L and any lymph nodes ≥ 5 cm in the long diameter or CLL/SLL or B-NHL patients with any lymph nodes ≥ 10 cm in the long diameter will be enrolled in the study after weighing the risks and benefits with the sponsor's MM. 9. Female patients of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of the investigational product; patients of childbearing potential (males and females) must agree to use a reliable birth control method (hormonal or barrier method or abstinence) with their partners from signing the ICF until 90 days after the last dose.The last ICP- 248 dose or within one month after the last dose of Orelabrutinib Or within 12 months after the last dose of Rituximab (whichever is longer). 10. Subjects are able to communicate with the investigator well and to complete the study as specified in the study. 11. 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). 12. Subjects with CLL/SLL must have an indication for treatment as judged by the investigator. Exclusion Criteria: 1. Prior malignancy (other than the disease under study) within 2 years before study entryKnown 2. Central nervous system involvement by lymphoma/leukemia 3. Underlying medical conditions that, in the investigator's opinion, will render the administration of the investigational product hazardous or obscure the interpretation of the safety or efficacy results. 4. Prior autologous stem cell transplant (unless ≥ 3 months after transplant); or prior chimeric cell therapy (unless ≥ 3 months after cell infusion). 5. Received a BCL-2 inhibitor prior to initial use of the investigational drug and did not achieve disease remission or disease recurrence/progression on treatment; Disease recurrence/progression after stopping or ending BCL-2 inhibitor therapy is acceptable. 6. A history of allogeneic stem cell transplantation. 7. Anti-cancer therapy within 14 days prior to the first dose of the investigational product 8. An interval of less than 5 half-lives from the last dose of a strong CYP3A inhibitor or inducer (chemical agent, traditional Chinese medicine and dietary supplement) to the first dose of the investigational product, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong CYP3A inhibitory or inductive effect during study participation. 9. Patients who have undergone major organ surgery (excluding aspiration biopsy) or significant trauma within 28 days prior to the first dose of the investigational product, or who require elective surgery during the trial. 10. Patients who have received a live attenuated vaccine within 28 days prior to the first dose of the investigational product (except for vaccination to prevent a major public health event). 11. Presence of active infection that currently requires intravenous systemic anti-infective therapy. 12. Patients with active hepatitis B or C virus infection. 13. History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test. 14. History of significant cardiovascular disease 15. Patients with previous or concomitant central nervous system disordersHistory or current evidence of severe interstitial lung disease. 16. ≥ Grade 2 toxicity due to prior anti-cancer therapy at enrollment (except for alopecia, ANC, hemoglobin and PLT). For ANC, hemoglobin and PLT, please follow the inclusion criteria. 17. History of severe bleeding disorder 18. Known alcohol or drug dependence. 19. Presence of mental disorders or poor compliance. 20. Female patients who are pregnant or lactating. 21. Unable to swallow tablets or disease significantly affecting gastrointestinal function. 22. Hypersensitivity to the active substance or excipients of ICP-248 tablets or Orelabrutinib tablets (only applicable to subjects in cohort G/H/J/K).Severe allergic reaction or intolerance to murine monoclonal antibodies or murine products. 23 Invasive mantle cell lymphoma, such as mother cell subtypes, polymorphic subtypes, or Ki-67 proliferation index\>50%, must be discussed with the sponsor's medical monitor regarding patient benefits and risks before being included in this study.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia diffuse large B-cell lymphoma follicular lymphoma hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm lymphoplasmacytic lymphoma mantle cell lymphoma marginal zone lymphoma

As listed by the trial registrant

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

Hematological malignancies

How to take part

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

  1. The places running it

    22 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

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Hematology Hospital, Chinese Academy of Medical Sciences

    RECRUITING

    Tianjin, Tianjin Municipality, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, Hunan, 410000, China

  • Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, 210029, China

  • Jiangxi Cancer Hospital

    RECRUITING

    Nanchang, Jiangxi, 330029, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Shandong cancer hospital

    RECRUITING

    Jinan, Shandong, 250117, China

  • Shenyang Hospital Of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110022, China

  • Sun Yat-Sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510062, China

  • The Central Hospital of Wuhan

    RECRUITING

    Wuhan, Hubei, 430014, 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, 233099, China

  • The First Affiliated Hospital of Chongqing Medical University

    RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • The First Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330000, 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, 310000, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, 450008, China

  • The Second Hospital of Dalian Medical University

    RECRUITING

    Dalian, Liaoning, 116027, 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, 610000, China

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