Overview

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of AZD0486 monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 to 80 years of age with relapsed or refractory B-NHL.

Principal investigator

Eligibility criteria

1. Key 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.
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Contact the study coordinator

Tara Graff
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