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

Description

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.

Conditions

B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma (FL), Diffuse Large B-Cell Lymphoma (DLBCL)

Study Overview

Study Details

Study overview

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.

A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

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

Condition
B-cell Non-Hodgkin Lymphoma
Intervention / Treatment

-

Contacts and Locations

Duarte

Research Site, Duarte, California, United States, 91010

Tampa

Research Site, Tampa, Florida, United States, 33612

Des Moines

Research Site, Des Moines, Iowa, United States, 50314

Overland Park

Research Site, Overland Park, Kansas, United States, 66204

Rochester

Research Site, Rochester, Minnesota, United States, 55905

Saint Louis

Research Site, Saint Louis, Missouri, United States, 63110

New Brunswick

Research Site, New Brunswick, New Jersey, United States, 08901

New York

Research Site, New York, New York, United States, 10016

Charlotte

Research Site, Charlotte, North Carolina, United States, 28203

Columbus

Research Site, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 2. Key
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2029-06-18