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

Inclusion Criteria

• 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

Exclusion Criteria

• 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