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New pill shows promise for tough blood cancers

NCT ID NCT05147467

Disease control Sponsor: Ascentage Pharma Group Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 called APG-2575 in people whose chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) has come back or stopped responding to other treatments. About 75 adults will take the drug alone to see if it can shrink tumors and control the disease. The goal is to find a new option for patients who have run out of effective therapies.

Why investors are watching

Ascentage Pharma is running a phase II registration trial of APG-2575 as a single drug in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. For a small company, this readout is a key test of whether the drug can work on its own and support a regulatory filing, which would be a major step for its pipeline.

If it works: A positive result could support a marketing application and give Ascentage a path to its first approved product in this indication. That would validate the drug's value and strengthen the company's position with regulators and partners.

If it fails: The trial could fail to show enough benefit or safety problems could emerge, which would delay or end the program. Trials in this setting often fail, and for a small company, a negative readout could hurt its prospects and financial position.

AI-written from the trial record. Speculative, and not investment advice.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 75 people

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

Started

Dec 2021

Expected to finish

Dec 2027

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 years and older

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: Subjects who meet each of the following inclusion criteria are eligible to participate in this study: 1. Age ≥18 years old. 2. Pathologically confirmed CLL/SLL according to the 2018 revised IWCLL NCI-WG guidelines, subject with measurable lesions or splenomegaly due to CLL. 3. Expected survival is at least 12 weeks. 4. Refractory, recurrent, or intolerant to BTK inhibitors and immunochemotherapy,or first-line treatment with BTK inhibitors fails and is not suitable for immunochemotherapy. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -2. 6. Ability to understand and willingness to sign a written informed consent form approved by EC committee (the consent form must be signed by the patient prior to any screening or study-specific procedures). 7. Willingness and ability to comply with study procedures and follow-up examination. Exclusion Criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: 1. Prior history of allogeneic hematopoietic stem cell transplantation, adoptive cell immunotherapy or autologous hematopoietic stem cell transplantation within 24 months. 2. Failure to recover adequately, at the discretion of the investigator, from prior surgical procedures. Patients who have had major surgery within 28 days from study entry, and patients who have had minor surgery within 14 days of study entry. 3. Received Bcl-2 inhibitor treatment. 4. Invasive NHL transformation or central nervous system (CNS) involvement has occurred. 5. Pregnancy or lactation, or pregnancy is expected during the study period or within 3 months after the last administration of treatment. 6. Within 2 years before entering the study, the subject had a history of active malignant tumors other than CLL / SLL, except that: * Fully treated cervical carcinoma in situ; * Completely resected basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; * Confinement and resection of previously cured malignancies (or other treatment). 7. Any other condition or circumstance that would, at the discretion of the investigator, make the patient unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Chronic lymphocytic leukemia Small lymphocytic lymphoma

How to take part

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

  1. The places running it

    11 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

  • Hainan General Hospital

    NOT_YET_RECRUITING

    Haikou, Hainan, 570311, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, 450003, China

  • Institute of blood transfusion of Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 215127, China

  • Nanfang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • People's hospital of Jiangsu Province

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

  • The First Affilated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, 330006, China

  • The First Affilated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    NOT_YET_RECRUITING

    Hanzhou, Zhejiang, 310003, China

  • Union Hospital medical college Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430022, China

  • Zhujiang Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510280, China

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