AZD0486 as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Inclusion Criteria

• Aged 18 to 80 years old

  • Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy

  • ECOG performance status 0 to 2

  • Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy

  • FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined as > 1.0 cm in its longest dimension)

  • Adequate hematological function: ANC ≥ 1000/mm3, platelets

    • 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening

  • Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)

  • Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min

  The above is a summary, other inclusion criteria details may apply.

2. Key

Exclusion Criteria

• Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
  • Active CNS involvement by B-NHL
  • Leukemic presentation of B-NHL
  • History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  • Prior therapy with T-cell engager (TCE) within 8 weeks, CAR T- cell therapy or autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, or prior allogeneic HSCT within 24 weeks of first dose of AZD0486
  • Requires chronic immunosuppressive therapy
  • Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
  • History of major cardiac abnormalities.
  • If female, participant must not be pregnant or breastfeeding.

The above is a summary, other exclusion criteria details may apply.