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

RecruitingPhase 2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
1. Key Inclusion Criteria:

   * Aged 18 years old and above
   * Histologically confirmed relapsed refractory FL (Module 1) and LBCL (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 or \< 5 × ULN in the presence of lymphoma involvement of the liver
   * Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
   * Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA

   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 of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.
   * Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
   * 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.

About the study

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (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 LBCL.

What is being tested

Sponsor: AstraZeneca · Participants: 270 · Started: Nov 27, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06526793

Locations in the U.S.

CaliforniaResearch Site, Duarte
FloridaResearch Site, Tampa
IllinoisResearch Site, Chicago
IowaResearch Site, Waukee
MinnesotaResearch Site, Rochester
New YorkResearch Site, New York
North CarolinaResearch Site, Charlotte
OhioResearch Site, Columbus
OregonResearch Site, Portland
PennsylvaniaResearch Site, Philadelphia
Research Site, Pittsburgh
TennesseeResearch Site, Nashville
TexasResearch Site, Austin
Research Site, Houston
Research Site, San Antonio (Not yet recruiting)
WisconsinResearch Site, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.