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New hope for Hard-to-Treat lymphoma: experimental drug DZD8586 enters phase 2 trial

NCT ID NCT06539195

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 05, 2026 · Updated 2 times

Summary

This phase 2 trial tests an experimental drug called DZD8586 in 59 adults with diffuse large B-cell lymphoma that has come back or not responded to previous treatment. The study aims to see if the drug can shrink tumors and to understand its side effects and how the body processes it. Participants take one of three daily doses of DZD8586.

What this could mean

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

Active substance
DZD8586
What this could lead to
If successful, this could provide a new oral treatment option for patients with DLBCL that has returned or not responded to prior therapy.
What could go wrong
This is a small, early-phase trial with no control group, so results may not confirm effectiveness. Side effects are still being studied.

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

59 people

The number who actually took part.

Started

Mar 2024

Finished

Jun 2026

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. Histologically confirmed recurrent or refractory DLBCL. 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 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. 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.

diffuse large B-cell lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • National Clinical Research Center for Blood Diseases, Blood Disease Hospital & Institute of Hematology, Chinese Academy of Medical Sciences & Peking Union Medical College

    Tianjin, Tianjin Municipality, 300020, China

  • Research Site

    Hefei, Anhui, 230031, China

  • Research Site

    Beijing, Beijing Municipality, 100083, China

  • Research Site

    Guangzhou, Guangdong, 510060, China

  • Research Site

    Nanning, Guangxi, 530016, China

  • Research Site

    Zhengzhou, Henan, 450003, China

  • Research Site

    Wuhan, Hubei, 430023, China

  • Research Site

    Changsha, Hunan, 410031, China

  • Research Site

    Jinan, Shandong, 250117, China

  • Research Site

    Linyi, Shandong, 276002, China

  • Research Site

    Xi’an, Shanxi, 710061, China

  • Research Site

    Chengdu, Sichuan, 610041, China

  • Research Site

    Tianjin, Tianjin Municipality, 300181, China

  • Research Site

    Hangzhou, Zhejiang, 310009, China

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