NCT05824585 DZD8586 in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
| NCT ID | NCT05824585 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Dizal Pharmaceuticals |
| Condition | Lymphoma, Non-Hodgkin |
| Study Type | INTERVENTIONAL |
| Enrollment | 230 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 230 participants in total. It began in 2023-05-15 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Tianwei Zhang
STUDY DIRECTOR
Dizal Pharma
Frequently Asked Questions
Who can join the NCT05824585 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, Non-Hodgkin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05824585 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05824585 currently recruiting?
Yes, NCT05824585 is actively recruiting participants. Contact the research team at ziyi.liu@dizalpharma.com for enrollment information.
Where is the NCT05824585 trial being conducted?
This trial is being conducted at New York, United States, Albury, Australia, Ballarat, Australia, Melbourne, Australia and 1 additional location.
Who is sponsoring the NCT05824585 clinical trial?
NCT05824585 is sponsored by Dizal Pharmaceuticals. The principal investigator is Tianwei Zhang at Dizal Pharma. The trial plans to enroll 230 participants.