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

Last updated: February 24, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

2

Condition

Follicular Lymphoma

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 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, 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: 240
Treatment Group(s): 2
Primary Treatment: AZD0486
Phase: 2
Study Start date:
November 27, 2024
Estimated Completion Date:
June 14, 2029

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 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

    Site Not Available

  • Research Site

    Heidelberg 2163654, 3084
    Australia

    Active - Recruiting

  • Research Site

    Kogarah, NSW 2217
    Australia

    Site Not Available

  • Research Site

    Kogarah 2161185, NSW 2217
    Australia

    Active - Recruiting

  • Research Site

    Macquarie University, 2109
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Site Not Available

  • Research Site

    Nedlands 2064874, 6009
    Australia

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035903
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre 3452925, 90035903
    Brazil

    Suspended

  • Research Site

    Sao Paulo, 01401-002
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 01401-002
    Brazil

    Active - Recruiting

  • Research Site

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Brampton, Ontario L6R 3J7
    Canada

    Site Not Available

  • Research Site

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Research Site

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Research Site

    Barrie 5894171, Ontario 6093943 L4M 6M2
    Canada

    Site Not Available

  • Research Site

    Brampton 5907364, Ontario 6093943 L6R 3J7
    Canada

    Active - Recruiting

  • Research Site

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Active - Recruiting

  • Research Site

    Toronto 6167865, Ontario 6093943 M5G 2M9
    Canada

    Active - Recruiting

  • Research Site

    Chengdu, 610072
    China

    Site Not Available

  • Research Site

    Chengdu 1815286, 610072
    China

    Active - Recruiting

  • Research Site

    Guangzhou, 510060
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858, 510060
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330029
    China

    Site Not Available

  • Research Site

    Nanchang 1800163, 330029
    China

    Active - Recruiting

  • Research Site

    Nanjing, 210029
    China

    Site Not Available

  • Research Site

    Nanjing 1799962, 210029
    China

    Active - Recruiting

  • Research Site

    Nantong, 226001
    China

    Site Not Available

  • Research Site

    Nantong 1799722, 226001
    China

    Active - Recruiting

  • Research Site

    Shandong,
    China

    Site Not Available

  • Research Site

    Shandong 7401388,
    China

    Site Not Available

  • Research Site

    Shandong 9617160,
    China

    Active - Recruiting

  • Research Site

    Shanghai, 200032
    China

    Site Not Available

  • Research Site

    Shanghai 1796236, 200025
    China

    Site Not Available

  • Research Site

    Tianjin, 300020
    China

    Site Not Available

  • Research Site

    Tianjin 1792947, 300020
    China

    Active - Recruiting

  • Research Site

    Zhengzhou, 450008
    China

    Site Not Available

  • Research Site

    Zhengzhou 1784658, 450008
    China

    Active - Recruiting

  • Research Site

    Aalborg, 9100
    Denmark

    Site Not Available

  • Research Site

    Aalborg 2624886, 9100
    Denmark

    Site Not Available

  • Research Site

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Research Site

    Copenhagen 2618425, 2100
    Denmark

    Active - Recruiting

  • Research Site

    Vejle, 7100
    Denmark

    Site Not Available

  • Research Site

    Vejle 2610613, 7100
    Denmark

    Active - Recruiting

  • Research Site

    Montpellier, 34295
    France

    Site Not Available

  • Research Site

    Montpellier 2992166, 34295
    France

    Active - Recruiting

  • Research Site

    Paris, 75010
    France

    Site Not Available

  • Research Site

    Paris 2988507, 75010
    France

    Active - Recruiting

  • Research Site

    Pierre Bénite, 69495
    France

    Site Not Available

  • Research Site

    Pierre-Bénite 2987314, 69495
    France

    Active - Recruiting

  • Research Site

    Rouen 2982652, 76038
    France

    Active - Recruiting

  • Research Site

    Rouen Cedex 1, 76038
    France

    Site Not Available

  • Research Site

    Berlin, 10967
    Germany

    Site Not Available

  • Research Site

    Berlin 2950159, 10967
    Germany

    Active - Recruiting

  • Research Site

    Chemnitz, 9116
    Germany

    Site Not Available

  • Research Site

    Chemnitz 2940132, 9116
    Germany

    Site Not Available

  • Research Site

    Essen, 45147
    Germany

    Site Not Available

  • Research Site

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Research Site

    Jena, 07747
    Germany

    Site Not Available

  • Research Site

    Jena 2895044, 07747
    Germany

    Active - Recruiting

  • Research Site

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Research Site

    Würzburg 2805615, 97080
    Germany

    Active - Recruiting

  • Research Site

    Hong Kong, 999077
    Hong Kong

    Site Not Available

  • Research Site

    Hong Kong 1819729, 999077
    Hong Kong

    Active - Recruiting

  • Research Site

    Shatin, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Shatin 1818920, 00000
    Hong Kong

    Site Not Available

  • Research Site

    Alessandria, 15121
    Italy

    Site Not Available

  • Research Site

    Alessandria 3183299, 15121
    Italy

    Active - Recruiting

  • Research Site

    Bologna, 40138
    Italy

    Site Not Available

  • Research Site

    Bologna 3181928, 40138
    Italy

    Active - Recruiting

  • Research Site

    Busto Arsizio, 21052
    Italy

    Site Not Available

  • Research Site

    Busto Arsizio 3181355, 21052
    Italy

    Active - Recruiting

  • Research Site

    Milan, 20141
    Italy

    Site Not Available

  • Research Site

    Milan 3173435, 20141
    Italy

    Site Not Available

  • Research Site

    Milan 6951411, 20141
    Italy

    Active - Recruiting

  • Research Site

    Milano, 20132
    Italy

    Site Not Available

  • Research Site

    Roma, 161
    Italy

    Site Not Available

  • Research Site

    Roma 8957247, 161
    Italy

    Site Not Available

  • Research Site

    Chiba 2113015, 260-8717
    Japan

    Active - Recruiting

  • Research Site

    Chiba-shi, 260-8717
    Japan

    Site Not Available

  • Research Site

    Kashiwa, 277-8577
    Japan

    Site Not Available

  • Research Site

    Kashiwa 1859924, 277-8577
    Japan

    Active - Recruiting

  • Research Site

    Koto-ku, 135-8550
    Japan

    Site Not Available

  • Research Site

    Kumamoto 1858421, 860-0008
    Japan

    Active - Recruiting

  • Research Site

    Kumamoto-shi, 860-0008
    Japan

    Site Not Available

  • Research Site

    Kōtoku 2128852, 135-8550
    Japan

    Active - Recruiting

  • Research Site

    Niigata 1855431, 951-8520
    Japan

    Active - Recruiting

  • Research Site

    Niigata-shi, 951-8520
    Japan

    Site Not Available

  • Research Site

    Okayama 1854383, 700-8558
    Japan

    Active - Recruiting

  • Research Site

    Okayama-shi, 700-8558
    Japan

    Site Not Available

  • Research Site

    Osaka 1853909, 541-8567
    Japan

    Active - Recruiting

  • Research Site

    Osaka-shi, 541-8567
    Japan

    Site Not Available

  • Research Site

    Yokohama 1848354, 241-8515
    Japan

    Active - Recruiting

  • Research Site

    Yokohama-shi, 241-8515
    Japan

    Site Not Available

  • Research Site

    Seoul, 5505
    Korea, Republic of

    Site Not Available

  • Research Site

    Seoul 1835848, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Research Site

    Barcelona 3128760, 08035
    Spain

    Active - Recruiting

  • Research Site

    Madrid, 28040
    Spain

    Site Not Available

  • Research Site

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • Research Site

    Pozuelo de Alarcon, 28223
    Spain

    Site Not Available

  • Research Site

    Pozuelo de Alarcón 3112989, 28223
    Spain

    Active - Recruiting

  • Research Site

    Goteborg, 41345
    Sweden

    Site Not Available

  • Research Site

    Gothenburg 2711537, 41345
    Sweden

    Active - Recruiting

  • Research Site

    Stockholm, 17176
    Sweden

    Site Not Available

  • Research Site

    Stockholm 2673730, 17176
    Sweden

    Active - Recruiting

  • Research Site

    Kaohsiung, 80756
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City, 833401
    Taiwan

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 80756
    Taiwan

    Site Not Available

  • Research Site

    Taichung, 40705
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan 1668355, 70403
    Taiwan

    Active - Recruiting

  • Research Site

    Tainan City, 70403
    Taiwan

    Site Not Available

  • Research Site

    Tainan City 1668355, 70403
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 106
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei City, 106
    Taiwan

    Site Not Available

  • Research Site

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, SE5 9RS
    United Kingdom

    Active - Recruiting

  • Research Site

    Manchester, M20 4BX
    United Kingdom

    Site Not Available

  • Research Site

    Manchester 2643123, M20 4BX
    United Kingdom

    Active - Recruiting

  • Research Site

    Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Research Site

    Norwich 2641181, NR4 7UY
    United Kingdom

    Active - Recruiting

  • Research Site

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Research Site

    Nottingham 2641170, NG5 1PB
    United Kingdom

    Active - Recruiting

  • Research Site

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Research Site

    Plymouth 2640194, PL6 8DH
    United Kingdom

    Active - Recruiting

  • Research Site

    Phoenix 5308655, Arizona 5551752 85054
    United States

    Site Not Available

  • Research Site

    Duarte, California 91010
    United States

    Site Not Available

  • Research Site

    Duarte 5344147, California 5332921 91010
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33612
    United States

    Site Not Available

  • Research Site

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Research Site

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Research Site

    Chicago 4887398, Illinois 4896861 60637
    United States

    Site Not Available

  • Research Site

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • Research Site

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Research Site

    Waukee 4880981, Iowa 4862182 50263
    United States

    Active - Recruiting

  • Research Site

    Overland Park, Kansas 66204
    United States

    Site Not Available

  • Research Site

    Overland Park 4276873, Kansas 4273857 66204
    United States

    Site Not Available

  • Research Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Research Site

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Active - Recruiting

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Research Site

    New Brunswick 5101717, New Jersey 5101760 08901
    United States

    Site Not Available

  • Research Site

    New York, New York 10016
    United States

    Site Not Available

  • Research Site

    New York 5128581, New York 5128638 10016
    United States

    Active - Recruiting

  • Research Site

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Research Site

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Research Site

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Research Site

    Columbus 4509177, Ohio 5165418 43210
    United States

    Active - Recruiting

  • Research Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Research Site

    Portland 5746545, Oregon 5744337 97239
    United States

    Active - Recruiting

  • Research Site

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • Research Site

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Active - Recruiting

  • Research Site

    Pittsburgh 5206379, Pennsylvania 6254927 15232
    United States

    Site Not Available

  • Research Site

    Nashville 4644585, Tennessee 4662168 37203
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Austin 4671654, Texas 4736286 78704
    United States

    Site Not Available

  • Research Site

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Research Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

  • Research Site

    Milwaukee 5263045, Wisconsin 5279468 53226
    United States

    Active - Recruiting

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