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

NCT ID: NCT06526793

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-27

Study Completion Date

2029-06-14

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

The trial will assess surovatamig (AZD0486) monotherapy given by IV infusion. Module 1 will evaluate the efficacy and safety of surovatamig monotherapy at the recommended Phase 2 dose (RP2D), in participants 18 years of age or older , with relapsed or refractory (R/R) follicular lymphoma (FL) who have received ≥ 2 prior therapies. Module 2 will evaluate the efficacy and safety of surovatamig monotherapy at the RP2D for participants 18 years of age or older with (R/R) large B-cell lymphoma (LBCL) who have received ≥ 2 prior therapies.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Surovatamig

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Surovatamig

Intervention Type DRUG

Investigational Product administered via intravenous infusion.

Interventions

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Surovatamig

Investigational Product administered via intravenous infusion.

Intervention Type DRUG

Other Intervention Names

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AZD0486

Eligibility Criteria

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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

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, 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Phoenix, Arizona, United States

Site Status NOT_YET_RECRUITING

Research Site

Duarte, California, United States

Site Status RECRUITING

Research Site

Jacksonville, Florida, United States

Site Status NOT_YET_RECRUITING

Research Site

Tampa, Florida, United States

Site Status RECRUITING

Research Site

Chicago, Illinois, United States

Site Status NOT_YET_RECRUITING

Research Site

Iowa City, Iowa, United States

Site Status NOT_YET_RECRUITING

Research Site

Waukee, Iowa, United States

Site Status RECRUITING

Research Site

Overland Park, Kansas, United States

Site Status WITHDRAWN

Research Site

Rochester, Minnesota, United States

Site Status RECRUITING

Research Site

St Louis, Missouri, United States

Site Status WITHDRAWN

Research Site

New Brunswick, New Jersey, United States

Site Status WITHDRAWN

Research Site

New York, New York, United States

Site Status RECRUITING

Research Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Research Site

Columbus, Ohio, United States

Site Status RECRUITING

Research Site

Portland, Oregon, United States

Site Status RECRUITING

Research Site

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Research Site

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Research Site

Nashville, Tennessee, United States

Site Status NOT_YET_RECRUITING

Research Site

Austin, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Houston, Texas, United States

Site Status RECRUITING

Research Site

San Antonio, Texas, United States

Site Status NOT_YET_RECRUITING

Research Site

Milwaukee, Wisconsin, United States

Site Status RECRUITING

Research Site

Heidelberg, , Australia

Site Status RECRUITING

Research Site

Kogarah, , Australia

Site Status RECRUITING

Research Site

Macquarie University, , Australia

Site Status RECRUITING

Research Site

Nedlands, , Australia

Site Status RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status SUSPENDED

Research Site

São Paulo, , Brazil

Site Status RECRUITING

Research Site

São Paulo, , Brazil

Site Status RECRUITING

Research Site

Barrie, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Brampton, Ontario, Canada

Site Status RECRUITING

Research Site

Ottawa, Ontario, Canada

Site Status RECRUITING

Research Site

Toronto, Ontario, Canada

Site Status RECRUITING

Research Site

Chengdu, , China

Site Status RECRUITING

Research Site

Chengdu, , China

Site Status RECRUITING

Research Site

Guangzhou, , China

Site Status RECRUITING

Research Site

Nanchang, , China

Site Status RECRUITING

Research Site

Nanjing, , China

Site Status RECRUITING

Research Site

Nantong, , China

Site Status RECRUITING

Research Site

Shandong, , China

Site Status RECRUITING

Research Site

Shanghai, , China

Site Status NOT_YET_RECRUITING

Research Site

Shanghai, , China

Site Status RECRUITING

Research Site

Tianjin, , China

Site Status RECRUITING

Research Site

Zhengzhou, , China

Site Status RECRUITING

Research Site

Aalborg, , Denmark

Site Status WITHDRAWN

Research Site

Copenhagen, , Denmark

Site Status RECRUITING

Research Site

Vejle, , Denmark

Site Status RECRUITING

Research Site

Montpellier, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Pierre-Bénite, , France

Site Status RECRUITING

Research Site

Rouen, , France

Site Status RECRUITING

Research Site

Berlin, , Germany

Site Status RECRUITING

Research Site

Chemnitz, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Essen, , Germany

Site Status NOT_YET_RECRUITING

Research Site

Jena, , Germany

Site Status RECRUITING

Research Site

Würzburg, , Germany

Site Status RECRUITING

Research Site

Hong Kong, , Hong Kong

Site Status RECRUITING

Research Site

Shatin, , Hong Kong

Site Status NOT_YET_RECRUITING

Research Site

Alessandria, , Italy

Site Status RECRUITING

Research Site

Bologna, , Italy

Site Status RECRUITING

Research Site

Busto Arsizio, , Italy

Site Status RECRUITING

Research Site

Milan, , Italy

Site Status RECRUITING

Research Site

Milan, , Italy

Site Status RECRUITING

Research Site

Roma, , Italy

Site Status NOT_YET_RECRUITING

Research Site

Chiba, , Japan

Site Status RECRUITING

Research Site

Kashiwa, , Japan

Site Status RECRUITING

Research Site

Kōtoku, , Japan

Site Status RECRUITING

Research Site

Kumamoto, , Japan

Site Status RECRUITING

Research Site

Niigata, , Japan

Site Status RECRUITING

Research Site

Okayama, , Japan

Site Status RECRUITING

Research Site

Osaka, , Japan

Site Status RECRUITING

Research Site

Yokohama, , Japan

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Madrid, , Spain

Site Status RECRUITING

Research Site

Pozuelo de Alarcón, , Spain

Site Status RECRUITING

Research Site

Gothenburg, , Sweden

Site Status RECRUITING

Research Site

Stockholm, , Sweden

Site Status RECRUITING

Research Site

Kaohsiung City, , Taiwan

Site Status WITHDRAWN

Research Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Tainan, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

London, , United Kingdom

Site Status RECRUITING

Research Site

Manchester, , United Kingdom

Site Status RECRUITING

Research Site

Norwich, , United Kingdom

Site Status RECRUITING

Research Site

Nottingham, , United Kingdom

Site Status RECRUITING

Research Site

Plymouth, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Brazil Canada China Denmark France Germany Hong Kong Italy Japan South Korea Spain Sweden Taiwan United Kingdom

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

1-877-240-9479

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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