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DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A Phase 1, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B-NHL)

NCT05824585•Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will treat patients with B-NHL who have relapsed, progressed, or were intolerant to systemic therapy progressed following prior therapy. This study will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and assess its anti-cancer activity as monotherapy.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female participants who have provided ICF with age ≥ 18 yrs
•2. ECOG performance 0-2, no deterioration in the past 2 weeks
•3. Participants with relapsed or refractory B-NHL must have cytologically or histologically confirmed B-cell lymphoma
•4. Adequate bone marrow reserve and organ system functions
•5. Participants willing to comply with contraceptive restrictions

Exclusion Criteria

•1. Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
•2. Prior history of allogeneic hematopoietic stem cell transplantation
•3. Stem cell transplantation, cell therapy, or gene therapy within 90 days. Approved small molecule therapy within 5 half-lives, investigational small molecule therapy within 14 days. Monoclonal antibodies and antibody-drug conjugates within 28 days Radiation therapy within 1 weeks
•4. Live attenuated vaccines or viral vector vaccines within 4 weeks. Major surgery or significant traumatic injury within 4 weeks. History of stroke or intracranial hemorrhage within 6 months
•5. Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
•6. CNSL participants with systemic presence of lymphoma, unable to complete lumbar puncture, under systemic corticosteroids at a dose \> 8 mg/day (dexamethasone equivalent dose) within 14 days or requiring immunosuppressive or biologic therapy."
•7. Participants with infectious disease:
•8. Clinically significant cardiac disorders or abnormalities
•9. Another malignancy within 5 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.
•10. Refractory nausea and vomiting if not controlled by supportive therapy, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption
+2 more criteria

Locations (5)

Research site

New York, New York, United States

Research site

Albury, New South Wales, Australia

Research site

Ballarat, Victoria, Australia

Research site

Melbourne, Victoria, Australia

Research site

Perth, Western Australia, Australia

Key Dates

Start Date

May 15, 2023

Primary Completion Date

April 30, 2027

Completion Date

October 30, 2027

Last Updated

August 11, 2025

Enrollment

230

ESTIMATED participants

Conditions

Lymphoma, Non-Hodgkin

Interventions

DZD8586

DRUG

Contacts

Ziyi Liu

CONTACT

+86 021 6109 5852 ziyi.liu@dizalpharma.com

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LymphomaFollicular Lymphoma+2 more

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RECRUITINGPHASE1/PHASE2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Inclusion Criteria

Exclusion Criteria

Epcoritamab in Patients With Follicular Lymphoma Not Accomplishing a CR With Upfront Chemoimmunotherapy

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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