Clinical Trial 22469

• Overview

  Study Title:

  A Modular Phase II, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

  Summary:

  This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

  Objective:

  Primary Objectives: To evaluate the efficacy of AZD0486 monotherapy administered at the RP2D in relapsed or refractory B-NHL. Secondary Objectives: To evaluate ORR and CR rate. To evaluate the efficacy of AZD0486 by evaluation of additional efficacy measures based on Lugano 2014 Response Criteria. To characterize the PK of AZD0486. To describe the incidence of immunogenicity. To evaluate patient-reported tolerability of AZD0486, including severity of key treatment-related symptoms and overall side-effect burden. To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns and general HRQoL, while on AZD0486. Evaluate the impact of AZD0486 on MRD-negative CR rate.

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  AZD0486 ()

• Inclusion Criteria

  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, liver and renal function
  • Other criteria may apply

• Exclusion Criteria

  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.
  • Other exclusions may apply

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