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

NCT05824585 | Recruiting Phase 1 FDA Drug

• 1 other identifier: DZ2022B0002
• Study Type: interventional
• Target: 230
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Lymphoma, Non-Hodgkin

Outcome Measures

Primary Outcomes (2)

• Part A: Incidence of adverse events

  30 days after the last dose, assessed up to 2 years

• Part B: Objective Response Rate assessed by investigators

  assessed up to 2 years

Secondary Outcomes (5)

• Part A: Objective Response Rate assessed by investigators

  assessed up to 2 years

• Part A: Plasma and CSF concentration of DZD8586

  through discontinuation of treatment up to 10 weeks

• Part B: Duration of Response assessed by investigators

  from date of first documented response until the date of documented progression, assessed up to 2 years

• Part B: Incidence of adverse events

  30 days after the last dose, assessed up to 2 years

• Part B: Plasma and CSF concentration of DZD8586

  through discontinuation of treatment, assessed up to 2 years

Study Arms (1)

DZD8586

EXPERIMENTAL

Drug: DZD8586

Interventions

DZD8586 DRUG

DZD8586 treatment starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD8586.

DZD8586

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Any unresolved \> Grade 1 adverse event at the time of starting study treatment with the exception of alopecia.
• Prior history of allogeneic hematopoietic stem cell transplantation
• 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
• 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
• Participants with non-CNSL presence of CNS or intraocular lymphoma lesions.
• 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."
• Participants with infectious disease:
• Clinically significant cardiac disorders or abnormalities
• 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.
• 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
• Women who are breast feeding
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (5)

Research site

New York, New York, 10065, United States

NOT YET RECRUITING

Research site

Albury, New South Wales, Australia

RECRUITING

Research site

Ballarat, Victoria, Australia

NOT YET RECRUITING

Research site

Melbourne, Victoria, Australia

RECRUITING

Research site

Perth, Western Australia, Australia

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Tianwei Zhang

  Dizal Pharma

  STUDY DIRECTOR

Central Study Contacts

Ziyi Liu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 21, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); AU (4)