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NCT06526793PHASE2Recruiting

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

AstraZeneca

Start Date

11/27/2024

Completion Date

10/21/2032

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.

Detailed Description

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of surovatamig (AZD0486) administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Surovatamig

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Conditions

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

Locations

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Phoenix, Arizona 85054

United States

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Duarte, California 91010

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Jacksonville, Florida 32224

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Tampa, Florida 33612

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Chicago, Illinois 60637

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Iowa City, Iowa 52242

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Waukee, Iowa 50263

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Overland Park, Kansas 66204

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Rochester, Minnesota 55905

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St Louis, Missouri 63110

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New Brunswick, New Jersey 08901

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New York, New York 10016

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Charlotte, North Carolina 28204

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Columbus, Ohio 43210

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Portland, Oregon 97239

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Philadelphia, Pennsylvania 19104

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Pittsburgh, Pennsylvania 15232

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Pittsburgh, Pennsylvania 15232

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Nashville, Tennessee 37203

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Austin, Texas 78704

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Houston, Texas 77030

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San Antonio, Texas 78229

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Milwaukee, Wisconsin 53226

United States

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Heidelberg, 3084

Australia

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Kogarah, NSW 2217

Australia

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Macquarie University, 2109

Australia

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Nedlands, 6009

Australia

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Porto Alegre, 90035903

Brazil

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São Paulo, 01401-002

Brazil

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São Paulo, 05652-900

Brazil

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Barrie, Ontario L4M 6M2

Canada

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Brampton, Ontario L6R 3J7

Canada

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Ottawa, Ontario K1H 8L6

Canada

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Toronto, Ontario M5G 2M9

Canada

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Chengdu, 610041

China

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Chengdu, 610072

China

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Guangzhou, 510060

China

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Nanchang, 330029

China

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Nanjing, 210029

China

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Nantong, 226001

China

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Shandong,

China

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Shanghai, 200025

China

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Shanghai, 200032

China

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Tianjin, 300020

China

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Zhengzhou, 450008

China

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Aalborg, 9100

Denmark

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Copenhagen, 2100

Denmark

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Vejle, 7100

Denmark

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Montpellier, 34295

France

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Paris, 75010

France

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Pierre-Bénite, 69495

France

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Rouen, 76038

France

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Berlin, 10967

Germany

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Chemnitz, 9116

Germany

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Essen, 45147

Germany

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Jena, 07747

Germany

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Würzburg, 97080

Germany

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Hong Kong, 999077

Hong Kong

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Shatin,

Hong Kong

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Alessandria, 15121

Italy

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Bologna, 40138

Italy

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Busto Arsizio, 21052

Italy

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Milan, 20132

Italy

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Milan, 20141

Italy

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Roma, 161

Italy

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Chiba, 260-8717

Japan

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Kashiwa, 277-8577

Japan

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Kōtoku, 135-8550

Japan

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Kumamoto, 860-0008

Japan

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Niigata, 951-8520

Japan

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Okayama, 700-8558

Japan

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Osaka, 541-8567

Japan

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Yokohama, 241-8515

Japan

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Seoul, 03080

South Korea

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Seoul, 06351

South Korea

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Seoul, 06591

South Korea

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Seoul, 3722

South Korea

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Seoul, 5505

South Korea

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Barcelona, 08035

Spain

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Madrid, 28040

Spain

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Pozuelo de Alarcón, 28223

Spain

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Gothenburg, 41345

Sweden

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Stockholm, 17176

Sweden

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 833401

Taiwan

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Taichung, 404

Taiwan

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Taichung, 40705

Taiwan

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Tainan, 70403

Taiwan

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Taipei, 106

Taiwan

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London, SE5 9RS

United Kingdom

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Manchester, M20 4BX

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Norwich, NR4 7UY

United Kingdom

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Nottingham, NG5 1PB

United Kingdom

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Plymouth, PL6 8DH

United Kingdom