Treatment of relapsed or refractory B-cell non-Hodgkin lymphoma with DZD8586
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)
This study is testing a new drug called DZD8586 to see if it can help people with relapsed or refractory B-cell non-Hodgkin lymphoma feel better and manage their cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 230 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dizal Pharmaceuticals Industry-sponsored |
| Drugs / interventions | Radiation |
| Locations | 5 sites (New York, New York and 4 other locations) |
| Trial ID | NCT05824585 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of DZD8586 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). Participants will receive the drug as a monotherapy, and the study aims to assess its anti-cancer activity while monitoring potential side effects. The trial will also evaluate the pharmacokinetics of DZD8586, measuring how the drug behaves in the body. Eligible patients must have confirmed B-NHL and meet specific health criteria to participate.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory B-cell non-Hodgkin lymphoma who have not responded to or cannot tolerate previous therapies.
Not a fit: Patients with unresolved severe adverse events from prior treatments or those who have undergone recent stem cell or gene therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell non-Hodgkin lymphoma.
How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in treating B-cell lymphomas with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 11. Women who are breast feeding 12. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol
Where this trial is running
New York, New York and 4 other locations
- Research site — New York, New York, 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)
Study contacts
- Study coordinator: Ziyi Liu
- Email: ziyi.liu@dizalpharma.com
- Phone: +86 021 6109 5852
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.