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

Last updated: June 22, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Follicular Lymphoma

Lymphoma, B-cell

Treatment

AZD0486

Surovatamig

Clinical Study ID

NCT06526793
D7404C00001
2023-505789-27-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

  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 fromlast 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 (definedas > 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 areallowed but counts must be stable for at least 72 hours afterwards priorto 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.

Exclusion

  1. 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 thatrequired treatment in the preceding year, is currently symptomatic, or that thetreating investigator considers to have the potential to interfere with theevaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke,severe brain injuries, dementia, neurodegenerative disorder includingParkinson's disease, cerebellar disease, organic brain syndrome, psychosis orother severe mental illness.

  • Prior therapy with T-cell engager (TCE) within 8 weeks, autologousHematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- celltherapy within 6 months, or prior allogeneic HSCT within 24 weeks of first doseof 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.

Study Design

Total Participants: 270
Treatment Group(s): 2
Primary Treatment: AZD0486
Phase: 2
Study Start date:
November 27, 2024
Estimated Completion Date:
October 21, 2032

Study 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.

Connect with a study center

  • Research Site

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • Research Site

    Kogarah, NSW 2217
    Australia

    Active - Recruiting

  • Research Site

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Site Not Available

  • Research Site

    Sao Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 01401-002
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 05652-900
    Brazil

    Active - Recruiting

  • Research Site

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Brampton, Ontario L6R 3J7
    Canada

    Active - Recruiting

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Chengdu, 610041
    China

    Active - Recruiting

  • Research Site

    Chengdu 1815286, 610072
    China

    Active - Recruiting

  • Research Site

    Guangzhou, 510060
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330029
    China

    Active - Recruiting

  • Research Site

    Nanjing, 210029
    China

    Active - Recruiting

  • Research Site

    Nantong, 226001
    China

    Active - Recruiting

  • Research Site

    Shandong,
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200032
    China

    Active - Recruiting

  • Research Site

    Shanghai 1796236, 200025
    China

    Site Not Available

  • Research Site

    Tianjin, 300020
    China

    Active - Recruiting

  • Research Site

    Zhengzhou, 450008
    China

    Active - Recruiting

  • Research Site

    Aalborg, 9100
    Denmark

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Research Site

    Vejle, 7100
    Denmark

    Active - Recruiting

  • Research Site

    Montpellier, 34295
    France

    Active - Recruiting

  • Research Site

    Paris, 75010
    France

    Active - Recruiting

  • Research Site

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Research Site

    Rouen, 76038
    France

    Active - Recruiting

  • Research Site

    Berlin, 10967
    Germany

    Active - Recruiting

  • Research Site

    Chemnitz, 9116
    Germany

    Active - Recruiting

  • Research Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Research Site

    Jena, 07747
    Germany

    Active - Recruiting

  • Research Site

    Würzburg, 97080
    Germany

    Active - Recruiting

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Research Site

    Shatin,
    Hong Kong

    Active - Recruiting

  • Research Site

    Alessandria, 15121
    Italy

    Active - Recruiting

  • Research Site

    Bologna, 40138
    Italy

    Active - Recruiting

  • Research Site

    Busto Arsizio, 21052
    Italy

    Active - Recruiting

  • Research Site

    Milan, 20141
    Italy

    Active - Recruiting

  • Research Site

    Milan 6951411, 20132
    Italy

    Active - Recruiting

  • Research Site

    Roma, 161
    Italy

    Site Not Available

  • Research Site

    Chiba, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Kashiwa, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto, 860-0008
    Japan

    Active - Recruiting

  • Research Site

    Kōtoku, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Niigata, 951-8520
    Japan

    Active - Recruiting

  • Research Site

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Osaka, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Yokohama, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Active - Recruiting

  • Research Site

    Pozuelo de Alarcón, 28223
    Spain

    Active - Recruiting

  • Research Site

    Gothenburg, 41345
    Sweden

    Active - Recruiting

  • Research Site

    Stockholm, 17176
    Sweden

    Active - Recruiting

  • Research Site

    Kaohsiung City, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung 1668399, 404
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 106
    Taiwan

    Active - Recruiting

  • Research Site

    London, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Norwich, NR4 7UY
    United Kingdom

    Active - Recruiting

  • Research Site

    Nottingham, NG5 1PB
    United Kingdom

    Active - Recruiting

  • Research Site

    Plymouth, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Research Site

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Active - Recruiting

  • Research Site

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Research Site

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    Waukee, Iowa 50263
    United States

    Active - Recruiting

  • Research Site

    Overland Park, Kansas 66204
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Research Site

    St Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Research Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Active - Recruiting

  • Research Site

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Research Site

    Austin, Texas 78704
    United States

    Active - Recruiting

  • Research Site

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Research Site

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Active - Recruiting

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