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

August 12, 2026 updated by: AstraZeneca

A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

270

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Heidelberg, Australia, 3084
        • Recruiting
        • Research Site
      • Kogarah, Australia, NSW 2217
        • Recruiting
        • Research Site
      • Macquarie University, Australia, 2109
        • Recruiting
        • Research Site
      • Nedlands, Australia, 6009
        • Recruiting
        • Research Site
      • Porto Alegre, Brazil, 90035903
        • Withdrawn
        • Research Site
      • São Paulo, Brazil, 05652-900
        • Recruiting
        • Research Site
      • São Paulo, Brazil, 01401-002
        • Recruiting
        • Research Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 6M2
        • Withdrawn
        • Research Site
      • Brampton, Ontario, Canada, L6R 3J7
        • Recruiting
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Research Site
      • Chengdu, China, 610041
        • Recruiting
        • Research Site
      • Chengdu, China, 610072
        • Recruiting
        • Research Site
      • Guangzhou, China, 510060
        • Recruiting
        • Research Site
      • Nanchang, China, 330029
        • Recruiting
        • Research Site
      • Nanjing, China, 210029
        • Recruiting
        • Research Site
      • Nantong, China, 226001
        • Recruiting
        • Research Site
      • Shandong, China
        • Recruiting
        • Research Site
      • Shanghai, China, 200025
        • Recruiting
        • Research Site
      • Shanghai, China, 200032
        • Recruiting
        • Research Site
      • Tianjin, China, 300020
        • Recruiting
        • Research Site
      • Zhengzhou, China, 450008
        • Recruiting
        • Research Site
      • Aalborg, Denmark, 9100
        • Withdrawn
        • Research Site
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Research Site
      • Vejle, Denmark, 7100
        • Recruiting
        • Research Site
      • Montpellier, France, 34295
        • Recruiting
        • Research Site
      • Paris, France, 75010
        • Recruiting
        • Research Site
      • Pierre-Bénite, France, 69495
        • Recruiting
        • Research Site
      • Rouen, France, 76038
        • Recruiting
        • Research Site
      • Berlin, Germany, 10967
        • Recruiting
        • Research Site
      • Chemnitz, Germany, 9116
        • Recruiting
        • Research Site
      • Essen, Germany, 45147
        • Recruiting
        • Research Site
      • Jena, Germany, 07747
        • Recruiting
        • Research Site
      • Würzburg, Germany, 97080
        • Recruiting
        • Research Site
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Research Site
      • Shatin, Hong Kong
        • Recruiting
        • Research Site
      • Alessandria, Italy, 15121
        • Recruiting
        • Research Site
      • Bologna, Italy, 40138
        • Recruiting
        • Research Site
      • Busto Arsizio, Italy, 21052
        • Recruiting
        • Research Site
      • Milan, Italy, 20132
        • Recruiting
        • Research Site
      • Milan, Italy, 20141
        • Recruiting
        • Research Site
      • Roma, Italy, 161
        • Withdrawn
        • Research Site
      • Chiba, Japan, 260-8717
        • Recruiting
        • Research Site
      • Kashiwa, Japan, 277-8577
        • Recruiting
        • Research Site
      • Kumamoto, Japan, 860-0008
        • Recruiting
        • Research Site
      • Kōtoku, Japan, 135-8550
        • Recruiting
        • Research Site
      • Niigata, Japan, 951-8520
        • Recruiting
        • Research Site
      • Okayama, Japan, 700-8558
        • Recruiting
        • Research Site
      • Osaka, Japan, 541-8567
        • Recruiting
        • Research Site
      • Yokohama, Japan, 241-8515
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Research Site
      • Seoul, South Korea, 5505
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Research Site
      • Seoul, South Korea, 3722
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08035
        • Recruiting
        • Research Site
      • Madrid, Spain, 28040
        • Recruiting
        • Research Site
      • Pozuelo de Alarcón, Spain, 28223
        • Recruiting
        • Research Site
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 17176
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 833401
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 80756
        • Withdrawn
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 404
        • Recruiting
        • Research Site
      • Tainan, Taiwan, 70403
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 106
        • Recruiting
        • Research Site
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Research Site
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • Research Site
      • Norwich, United Kingdom, NR4 7UY
        • Recruiting
        • Research Site
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Research Site
      • Plymouth, United Kingdom, PL6 8DH
        • Recruiting
        • Research Site
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Withdrawn
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • Research Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Withdrawn
        • Research Site
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Withdrawn
        • Research Site
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • Research Site
    • Kansas
      • Overland Park, Kansas, United States, 66204
        • Withdrawn
        • Research Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Research Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Withdrawn
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Withdrawn
        • Research Site
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Research Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Withdrawn
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Research Site
    • Texas
      • Austin, Texas, United States, 78704
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77030
        • Recruiting
        • Research Site
      • San Antonio, Texas, United States, 78229
        • Not yet recruiting
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Investigational Product administered via intravenous infusion.
Other Names:
  • AZD0486
Experimental: 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.
Investigational Product administered via intravenous infusion.
Other Names:
  • AZD0486

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) (central review)
Time Frame: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.
Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a Partial Response (PR) or Complete Response (CR) based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review
Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DoR)
Time Frame: To be assessed up to approximately 5 years.
Defined as the time from the date of first documented response until date of documented progression by Lugano 2014 response criteria as determined by central review or death due to any cause.
To be assessed up to approximately 5 years.
Time to response (TTR)
Time Frame: From the first dose until the first objective response, up to approximately 5 years.
Defined as the time from first dose until first documented objective response, as assessed by central review.
From the first dose until the first objective response, up to approximately 5 years.
Event-free survival (EFS)
Time Frame: To be assessed up to approximately 5 years
Defined as the time from first dose until disease progression, relapse, or initiation of subsequent systemic anti-lymphoma treatment, or death due to any cause, as assessed by central review.
To be assessed up to approximately 5 years
Progression-free survival (PFS)
Time Frame: To be assessed up to approximately 5 years.
Defined as the time from the date of first dose until documented disease progression based on Lugano 2014 Response Criteria, or death due to any cause.
To be assessed up to approximately 5 years.
Overall survival (OS)
Time Frame: To be assessed up to approximately 5 years.
Defined as the time from first dose until the date of death due to any cause.
To be assessed up to approximately 5 years.
Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)
Time Frame: From time of Informed Consent to 90-day safety follow-up visit

Incidence, nature, and severity of AEs/SAEs (based on NCI CTCAE v5.0/ASTCT criteria/Cairo-Bishop criteria with Howard modification) and changes in laboratory data, vital signs, and electrocardiograms (ECGs) compared with baseline.

Incidence and severity of AESIs.

From time of Informed Consent to 90-day safety follow-up visit
Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)
Time Frame: From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2
Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs
From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2
Complete response (CR) rate (central review)
Time Frame: To be assessed up through study completion, up to approximately 5 years
Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.
To be assessed up through study completion, up to approximately 5 years
Complete response (CR) rate (investigator assessment)
Time Frame: To be assessed up through study completion, up to approximately 5 years
Complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
To be assessed up through study completion, up to approximately 5 years
Duration of complete response (DoCR)
Time Frame: To be assessed up to approximately 5 years.
Defined as the time from achievement of complete response (CR) to relapse or death due any cause, as assessed by central review
To be assessed up to approximately 5 years.
Plasma concentrations of surovatamig
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
To characterize the plasma concentration of surovatamig as monotherapy
From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
Area under the concentration time curve (AUC)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
To characterize the pharmacokinetics (PK) AUC of surovatamig as monotherapy
From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
Maximum plasma concentration (Cmax)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
To characterize the pharmacokinetics (PK) (Cmax) of surovatamig as monotherapy
From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
Time to maximum plasma concentration (Tmax)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
To characterize the pharmacokinetics (PK) (Tmax) of surovatamig as monotherapy
From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
A trough concentration (Cthrough)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
To characterize the pharmacokinetics (PK) (C through) of surovatamig as monotherapy
From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
Immunogenecity of surovatamig
Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2)
The number and percentage of participants who develop Anti-Drug Antibodies (ADAs)
From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2)
Change from baseline in FACT-LymS scales
Time Frame: To be assessed up through study completion, up to approximately 5 years

To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig

Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) FACT-LymS - Lymphoma-specific Subscale from the FACT-Lym Questionnaire is a 15-item questionnaire, and each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much).

To be assessed up through study completion, up to approximately 5 years
Overall response rate (ORR) (investigator assessment)
Time Frame: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a partial response (PR) or complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
Time to next anti-lymphoma (TTNT)
Time Frame: To be assessed up to approximately 5 years.
Defined as time from first dose until the start date of subsequent anti-lymphoma therapy or death due to any cause.
To be assessed up to approximately 5 years.
Change from baseline in EORTC IL233 scales
Time Frame: To be assessed up through study completion, up to approximately 5 years

To evaluate patient-reported tolerability of surovatamig, including severity of key treatment-related symptoms and overall side-effect burden. IL233 will evaluate different levels of severity in fatigue, pain and cognition.

EORCT IL233 scales - European Organisation for Research and Treatment of Cancer Il233 scales- this questionnaire is assessing Patient-reported Severity of Treatment-and Disease-related Symptoms, it is a 15-item questionnaire, and each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much).

To be assessed up through study completion, up to approximately 5 years
Change from baseline in PGI-TT scale
Time Frame: To be assessed up through study completion, up to approximately 5 years

To evaluate patient-reported tolerability of surovatamig, overall side-effect burden.

PGI-TT scale - Patient Global Impression of Treatment Tolerability is a 1 item questionnaire rated on a 7-point scale ranging from "not at all" to "very much"

To be assessed up through study completion, up to approximately 5 years
Change from baseline in EORTC IL 232 QL2 scores
Time Frame: To be assessed up through study completion, up to approximately 5 years

To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig.

European Organization for Research and Treatment of Cancer (EORTC) IL 232 will be used to evaluate impacts on function and HRQoL (health-related quality of life) due to treatment and disease, which includes 13 EORTC QLQ-C30 function items assessing physical, social, role, and emotional function, as well as the EORTC QLQ-C30's 2 global health/HRQoL items.

To be assessed up through study completion, up to approximately 5 years
Minimal residual disease (MRD)
Time Frame: To be assessed up through study completion, up to approximately 5 years
MRD-negative complete response (CR) summarized through MRD-negative rate, defined as the proportion of participants who achieved MRD-negativity in plasma by next generation sequencing (NGS) while in complete response (CR) per the Lugano Response criteria for non-Hodgkin lymphoma as determined by central review.
To be assessed up through study completion, up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2024

Primary Completion (Estimated)

April 21, 2028

Study Completion (Estimated)

October 21, 2032

Study Registration Dates

First Submitted

July 3, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements: thttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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