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New hope for blood cancer patients: experimental drug DZD8586 enters phase 2 trial

NCT ID NCT06539182

Disease control Sponsor: Dizal Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental drug called DZD8586 (Birelentinib) in 155 adults with chronic lymphocytic leukemia or small lymphocytic lymphoma that has returned or not responded to prior treatment. Participants take one of three daily doses to see if the drug shrinks tumors and to check for side effects. The goal is to find a new treatment option for this hard-to-treat blood cancer.

What this could mean

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

Active substance
DZD8586 (Birelentinib)
What this could lead to
If successful, this could offer a new oral treatment option for people with CLL/SLL whose cancer has returned or stopped responding to other therapies.
What could go wrong
This is a Phase 2 trial with a moderate number of participants, so results are still preliminary. The drug may cause side effects or not work for everyone.

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 155 people

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

Started

Apr 2024

Expected to finish

Mar 2028

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: Participants who meet all the following criteria: 1. Male and female ≥ 18 years of age. 2. ECOG performance status 0-2. 3. Confirmed diagnosis of CLL/SLL with indication for treatment. 4. Adequate bone marrow reserve and organ system functions. 5. Willing to comply with contraceptive restrictions. Exclusion Criteria: Participants who meet any of the following criteria: 1. CNS involvement or Richter transformation. 2. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, monoclonal antibodies and antibody-drug conjugates within 28 days. 3. Major surgery or significant traumatic injury within 4 weeks. Live attenuated vaccines or viral vector vaccines within 4 weeks. 4. Take vitamin K antagonists or take more than 2 anticoagulants or antiplatelet drugs at the same time. Take proton pump inhibitors or strong CYP3A inhibitors or inducers. 5. Active infection. 6. Clinically significant cardiac disorders or abnormalities. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months. 7. Nausea and vomiting not controlled or chronic gastrointestinal diseases, unable to swallow the formulated product or previous bowel resection that would preclude adequate absorption. 8. Another malignancy within 2 years prior to enrollment with the exception of adequately treated in-situ carcinoma of the cervix, uterus, basal or squamous cell carcinoma or non-melanomatous skin cancer. 9. Women who are breast feeding. 10. History of hypersensitivity to active or inactive excipients of DZD8586 or drugs with a similar chemical structure or class.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia chronic lymphocytic leukemia/small lymphocytic lymphoma

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

    17 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

  • First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

    RECRUITING

    Nanjing, Jiangsu, China

  • Research Site

    RECRUITING

    Hefei, Anhui, China

  • Research Site

    RECRUITING

    Beijing, Beijing Municipality, 100053, China

  • Research Site

    RECRUITING

    Beijing, Beijing Municipality, 100191, China

  • Research Site

    RECRUITING

    Guangzhou, Guandong, 510280, China

  • Research Site

    RECRUITING

    Guangzhou, Guandong, 510515, China

  • Research Site

    RECRUITING

    Zhengzhou, Henan, China

  • Research Site

    RECRUITING

    Wuhan, Hubei, China

  • Research Site

    RECRUITING

    Changchun, Jilin, China

  • Research Site

    NOT_YET_RECRUITING

    Dalian, Liaoning, China

  • Research Site

    RECRUITING

    Shenyang, Liaoning, China

  • Research Site

    RECRUITING

    Jinan, Shandong, China

  • Research Site

    RECRUITING

    Linyi, Shandong, China

  • Research Site

    RECRUITING

    Shanghai, Shanghai Municipality, China

  • Research Site

    RECRUITING

    Taiyuan, Shangxi, China

  • Research Site

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Research Site

    RECRUITING

    Tianjin, Tianjin Municipality, 300060, China

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