RecruitingPhase 2NCT06526793

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

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)

Sponsor

AstraZeneca

Enrollment

240 participants

Start Date

Nov 27, 2024

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called surovatamig (AZD0486) as a single treatment for people with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) — specifically follicular lymphoma (FL) and large B-cell lymphoma (LBCL). Surovatamig is a bispecific antibody that connects T cells (immune cells) directly to CD19, a protein found on lymphoma cells, helping the immune system target and destroy them. **You may be eligible if...** - You are 18 or older - You have confirmed follicular lymphoma (Module 1) or large B-cell lymphoma (Module 2) that has returned or not responded after at least 2 prior treatments - Your lymphoma cells still express CD19 (confirmed after your last CD19-targeting therapy) - You have at least one measurable tumor on a PET scan - Your blood counts, liver, kidney, and heart function meet the required levels **You may NOT be eligible if...** - You have chronic lymphocytic leukemia (CLL), Burkitt lymphoma, or Richter's transformation - Your lymphoma has spread to the central nervous system (brain or spinal cord) - You have had CAR-T therapy within the past 6 months or a bone marrow transplant within recent months - You require chronic immunosuppressant medications - You have significant heart problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSurovatamig

Investigational Product administered via intravenous infusion.

Locations(94)

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Phoenix, Arizona, United States

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Duarte, California, United States

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Jacksonville, Florida, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Iowa City, Iowa, United States

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Waukee, Iowa, United States

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Overland Park, Kansas, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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New Brunswick, New Jersey, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Columbus, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Milwaukee, Wisconsin, United States

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Heidelberg, Australia

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Kogarah, Australia

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Macquarie University, Australia

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Nedlands, Australia

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Porto Alegre, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Barrie, Ontario, Canada

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Brampton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Chengdu, China

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Chengdu, China

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Guangzhou, China

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Nanchang, China

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Nanjing, China

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Nantong, China

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Shandong, China

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Shanghai, China

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Shanghai, China

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Tianjin, China

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Zhengzhou, China

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Aalborg, Denmark

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Copenhagen, Denmark

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Vejle, Denmark

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Montpellier, France

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Paris, France

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Pierre-Bénite, France

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Rouen, France

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Berlin, Germany

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Chemnitz, Germany

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Essen, Germany

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Jena, Germany

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Würzburg, Germany

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Hong Kong, Hong Kong

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Shatin, Hong Kong

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Alessandria, Italy

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Bologna, Italy

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Busto Arsizio, Italy

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Milan, Italy

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Milan, Italy

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Roma, Italy

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Chiba, Japan

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Kashiwa, Japan

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Kōtoku, Japan

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Kumamoto, Japan

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Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Yokohama, Japan

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Madrid, Spain

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Pozuelo de Alarcón, Spain

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Gothenburg, Sweden

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Stockholm, Sweden

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Taichung, Taiwan

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Tainan, Taiwan

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Taipei, Taiwan

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London, United Kingdom

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Manchester, United Kingdom

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Norwich, United Kingdom

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Nottingham, United Kingdom

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Plymouth, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06526793