Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05824585

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

Led by Dizal Pharmaceuticals · Updated on 2025-08-11

230

Participants Needed

5

Research Sites

232 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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
Not Eligible

You will not qualify if you...

  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
  11. Women who are breast feeding
  12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Research site

New York, New York, United States, 10065

Not Yet Recruiting

2

Research site

Albury, New South Wales, Australia

Actively Recruiting

3

Research site

Ballarat, Victoria, Australia

Not Yet Recruiting

4

Research site

Melbourne, Victoria, Australia

Actively Recruiting

5

Research site

Perth, Western Australia, Australia

Actively Recruiting

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Research Team

Z

Ziyi Liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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