RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: AstraZeneca • ClinicalTrials.gov ID: NCT06526793

Registry updated: 2026-10-14

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Description

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.

Interventions

Surovatamig (Drug)
Investigational Product administered via intravenous infusion.

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.

Conditions

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

Locations

Research Site — Phoenix, Arizona, United States
Research Site — Duarte, California, United States
Research Site — Jacksonville, Florida, United States
Research Site — Tampa, Florida, United States
Research Site — Chicago, Illinois, United States
Research Site — Iowa City, Iowa, United States
Research Site — Waukee, Iowa, United States
Research Site — Overland Park, Kansas, United States
Research Site — Rochester, Minnesota, United States
Research Site — St Louis, Missouri, United States
Research Site — New Brunswick, New Jersey, United States
Research Site — New York, New York, United States
Research Site — Charlotte, North Carolina, United States
Research Site — Columbus, Ohio, United States
Research Site — Portland, Oregon, United States
Research Site — Philadelphia, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Pittsburgh, Pennsylvania, United States
Research Site — Nashville, Tennessee, United States
Research Site — Austin, Texas, United States
Research Site — Houston, Texas, United States
Research Site — San Antonio, Texas, United States
Research Site — Milwaukee, Wisconsin, United States
Research Site — Heidelberg, Australia
Research Site — Kogarah, Australia
Research Site — Macquarie University, Australia
Research Site — Nedlands, Australia
Research Site — Porto Alegre, Brazil
Research Site — São Paulo, Brazil
Research Site — São Paulo, Brazil
Research Site — Barrie, Ontario, Canada
Research Site — Brampton, Ontario, Canada
Research Site — Ottawa, Ontario, Canada
Research Site — Toronto, Ontario, Canada
Research Site — Chengdu, China
Research Site — Chengdu, China
Research Site — Guangzhou, China
Research Site — Nanchang, China
Research Site — Nanjing, China
Research Site — Nantong, China
Research Site — Shandong, China
Research Site — Shanghai, China
Research Site — Shanghai, China
Research Site — Tianjin, China
Research Site — Zhengzhou, China
Research Site — Aalborg, Denmark
Research Site — Copenhagen, Denmark
Research Site — Vejle, Denmark
Research Site — Montpellier, France
Research Site — Paris, France
Research Site — Pierre-Bénite, France
Research Site — Rouen, France
Research Site — Berlin, Germany
Research Site — Chemnitz, Germany
Research Site — Essen, Germany
Research Site — Jena, Germany
Research Site — Würzburg, Germany
Research Site — Hong Kong, Hong Kong
Research Site — Shatin, Hong Kong
Research Site — Alessandria, Italy
Research Site — Bologna, Italy
Research Site — Busto Arsizio, Italy
Research Site — Milan, Italy
Research Site — Milan, Italy
Research Site — Roma, Italy
Research Site — Chiba, Japan
Research Site — Kashiwa, Japan
Research Site — Kōtoku, Japan
Research Site — Kumamoto, Japan
Research Site — Niigata, Japan
Research Site — Okayama, Japan
Research Site — Osaka, Japan
Research Site — Yokohama, Japan
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Seoul, South Korea
Research Site — Barcelona, Spain
Research Site — Madrid, Spain
Research Site — Pozuelo de Alarcón, Spain
Research Site — Gothenburg, Sweden
Research Site — Stockholm, Sweden
Research Site — Kaohsiung City, Taiwan
Research Site — Kaohsiung City, Taiwan
Research Site — Taichung, Taiwan
Research Site — Taichung, Taiwan
Research Site — Tainan, Taiwan
Research Site — Taipei, Taiwan
Research Site — London, United Kingdom
Research Site — Manchester, United Kingdom
Research Site — Norwich, United Kingdom
Research Site — Nottingham, United Kingdom
Research Site — Plymouth, United Kingdom

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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