Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
NCT ID: NCT06526793
Last Updated: 2026-01-21
Study Results
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Basic Information
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RECRUITING
PHASE2
240 participants
INTERVENTIONAL
2024-11-27
2029-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
In Module 1, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R FL. Surovatamig will be administered as intravenous infusion.
Surovatamig
Investigational Product administered via intravenous infusion.
Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL
In Module 2, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R LBCL. Surovatamig will be administered as intravenous infusion.
Surovatamig
Investigational Product administered via intravenous infusion.
Interventions
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Surovatamig
Investigational Product administered via intravenous infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, or 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.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
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
Countries
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Central Contacts
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Other Identifiers
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2023-505789-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7404C00001
Identifier Type: -
Identifier Source: org_study_id
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