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

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. - SOUNDTRACK-B

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240051

Enrollment

Registered

2024-08-21

Start date

2025-01-07

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

- Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma Drug: AZD0486 Investigational Product administered via intravenous infusion. - Module 2: AZD0486 Monoth

Eligibility

Sex/Gender

All

Inclusion criteria

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 or more, platelets 75,000/mm3 or more, hemoglobin 9 g/dL or more. 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 or less 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 or more

Exclusion criteria

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 or more from prior therapies; history of Grade 3 or more CRS or neurotoxicity from prior CAR-T or TCE therapy - History of major cardiac abnormalities. - If female, participant must not be pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC	—

Countries

Australia, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, Italy, Japan, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactKazushige Hibi

Astrazeneka K.K

RD-clinical-information-Japan@astrazeneca.com+81-6-4802-3533

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026