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B-cell Non-Hodgkin LymphomaPhase 2SOUNDTRACK-BNCT06526793

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

A Phase 2 study testing Surovatamig in people with B-cell Non-Hodgkin Lymphoma and Follicular Lymphoma (FL), run by AstraZeneca at 94 sites in 16 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surovatamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
94 sitesin 16 countries
Study dates
27 Nov 2024to 21 Oct 2032
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult
  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.
  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 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.

Trial locations and contacts

94 sites in 16 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

94 sites in 16 countries

United States23 sites, 16 recruiting
  • Research Site

    Austin, Texas, 78704

    Recruiting
  • Research Site

    Charlotte, North Carolina, 28204

    Recruiting
  • Research Site

    Chicago, Illinois, 60637

    Recruiting
  • Research Site

    Columbus, Ohio, 43210

    Recruiting
  • Research Site

    Duarte, California, 91010

    Recruiting
  • Research Site

    Houston, Texas, 77030

    Recruiting
  • Research Site

    Iowa City, Iowa, 52242

    Withdrawn
  • Research Site

    Jacksonville, Florida, 32224

    Withdrawn
  • Research Site

    Milwaukee, Wisconsin, 53226

    Recruiting
  • Research Site

    Nashville, Tennessee, 37203

    Recruiting
  • Research Site

    New Brunswick, New Jersey, 08901

    Withdrawn
  • Research Site

    New York, New York, 10016

    Recruiting
  • Research Site

    Overland Park, Kansas, 66204

    Withdrawn
  • Research Site

    Philadelphia, Pennsylvania, 19104

    Recruiting
  • Research Site

    Phoenix, Arizona, 85054

    Withdrawn
  • Research Site

    Pittsburgh, Pennsylvania, 15232

    Recruiting
  • Research Site

    Pittsburgh, Pennsylvania, 15232

    Withdrawn
  • Research Site

    Portland, Oregon, 97239

    Recruiting
  • Research Site

    Rochester, Minnesota, 55905

    Recruiting
  • Research Site

    San Antonio, Texas, 78229

    Recruiting
  • Research Site

    St Louis, Missouri, 63110

    Withdrawn
  • Research Site

    Tampa, Florida, 33612

    Recruiting
  • Research Site

    Waukee, Iowa, 50263

    Recruiting

Other trials in United States

China11 sites, 11 recruiting
  • Research Site

    Chengdu, 610041

    Recruiting
  • Research Site

    Chengdu, 610072

    Recruiting
  • Research Site

    Guangzhou, 510060

    Recruiting
  • Research Site

    Nanchang, 330029

    Recruiting
  • Research Site

    Nanjing, 210029

    Recruiting
  • Research Site

    Nantong, 226001

    Recruiting
  • Research Site

    Shandong

    Recruiting
  • Research Site

    Shanghai, 200025

    Recruiting
  • Research Site

    Shanghai, 200032

    Recruiting
  • Research Site

    Tianjin, 300020

    Recruiting
  • Research Site

    Zhengzhou, 450008

    Recruiting

Other trials in China

Japan8 sites, 8 recruiting
  • Research Site

    Chiba, 260-8717

    Recruiting
  • Research Site

    Kashiwa, 277-8577

    Recruiting
  • Research Site

    Kōtoku, 135-8550

    Recruiting
  • Research Site

    Kumamoto, 860-0008

    Recruiting
  • Research Site

    Niigata, 951-8520

    Recruiting
  • Research Site

    Okayama, 700-8558

    Recruiting
  • Research Site

    Osaka, 541-8567

    Recruiting
  • Research Site

    Yokohama, 241-8515

    Recruiting

Other trials in Japan

Italy6 sites, 5 recruiting
  • Research Site

    Alessandria, 15121

    Recruiting
  • Research Site

    Bologna, 40138

    Recruiting
  • Research Site

    Busto Arsizio, 21052

    Recruiting
  • Research Site

    Milan, 20132

    Recruiting
  • Research Site

    Milan, 20141

    Recruiting
  • Research Site

    Roma, 161

    Withdrawn

Other trials in Italy

Taiwan6 sites, 5 recruiting
  • Research Site

    Kaohsiung City, 80756

    Withdrawn
  • Research Site

    Kaohsiung City, 833401

    Recruiting
  • Research Site

    Taichung, 404

    Recruiting
  • Research Site

    Taichung, 40705

    Recruiting
  • Research Site

    Tainan, 70403

    Recruiting
  • Research Site

    Taipei, 106

    Recruiting

Other trials in Taiwan

Germany5 sites, 5 recruiting
  • Research Site

    Berlin, 10967

    Recruiting
  • Research Site

    Chemnitz, 9116

    Recruiting
  • Research Site

    Essen, 45147

    Recruiting
  • Research Site

    Jena, 07747

    Recruiting
  • Research Site

    Würzburg, 97080

    Recruiting

Other trials in Germany

South Korea5 sites, 5 recruiting
  • Research Site

    Seoul, 03080

    Recruiting
  • Research Site

    Seoul, 06351

    Recruiting
  • Research Site

    Seoul, 06591

    Recruiting
  • Research Site

    Seoul, 3722

    Recruiting
  • Research Site

    Seoul, 5505

    Recruiting

Other trials in South Korea

United Kingdom5 sites, 5 recruiting
  • Research Site

    London, SE5 9RS

    Recruiting
  • Research Site

    Manchester, M20 4BX

    Recruiting
  • Research Site

    Norwich, NR4 7UY

    Recruiting
  • Research Site

    Nottingham, NG5 1PB

    Recruiting
  • Research Site

    Plymouth, PL6 8DH

    Recruiting

Other trials in United Kingdom

Australia4 sites, 4 recruiting
  • Research Site

    Heidelberg, 3084

    Recruiting
  • Research Site

    Kogarah, NSW 2217

    Recruiting
  • Research Site

    Macquarie University, 2109

    Recruiting
  • Research Site

    Nedlands, 6009

    Recruiting

Other trials in Australia

Canada4 sites, 3 recruiting
  • Research Site

    Barrie, Ontario, L4M 6M2

    Withdrawn
  • Research Site

    Brampton, Ontario, L6R 3J7

    Recruiting
  • Research Site

    Ottawa, Ontario, K1H 8L6

    Recruiting
  • Research Site

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

France4 sites, 4 recruiting
  • Research Site

    Montpellier, 34295

    Recruiting
  • Research Site

    Paris, 75010

    Recruiting
  • Research Site

    Pierre-Bénite, 69495

    Recruiting
  • Research Site

    Rouen, 76038

    Recruiting

Other trials in France

Brazil3 sites
  • Research Site

    Porto Alegre, 90035903

    Withdrawn
  • Research Site

    São Paulo, 01401-002

    Active, not recruiting
  • Research Site

    São Paulo, 05652-900

    Active, not recruiting

Other trials in Brazil

Denmark3 sites, 2 recruiting
  • Research Site

    Aalborg, 9100

    Withdrawn
  • Research Site

    Copenhagen, 2100

    Recruiting
  • Research Site

    Vejle, 7100

    Recruiting

Other trials in Denmark

Spain3 sites, 3 recruiting
  • Research Site

    Barcelona, 08035

    Recruiting
  • Research Site

    Madrid, 28040

    Recruiting
  • Research Site

    Pozuelo de Alarcón, 28223

    Recruiting

Other trials in Spain

Hong Kong2 sites, 2 recruiting
  • Research Site

    Hong Kong, 999077

    Recruiting
  • Research Site

    Shatin

    Recruiting

Other trials in Hong Kong

Sweden2 sites, 2 recruiting
  • Research Site

    Gothenburg, 41345

    Recruiting
  • Research Site

    Stockholm, 17176

    Recruiting

Other trials in Sweden

About this study

Official title: 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.

Read the 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.

Being tested
Surovatamig
Keywords
AZD0486, Surovatamig, Follicular Lymphoma (FL), Large B-Cell Lymphoma (LBCL), Non-Hodgkin lymphoma (NHL), Relapsed/Refractory
Medical subject headings
Lymphoma, B-Cell, Lymphoma, Follicular, Lymphoma, Non-Hodgkin, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurovatamigDrug

    Also called AZD0486

    Investigational Product administered via intravenous infusion.

Study groups in NCT06526793
Study groupRoleWhat they receive
Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular LymphomaExperimentalIn 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.
Receives: Drug: Surovatamig
Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCLExperimentalIn 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.
Receives: Drug: Surovatamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR) (central review)

    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

    Measured: 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 outcomes (23)
  1. Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)

    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.

    Measured: From time of Informed Consent to 90-day safety follow-up visit

  2. Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)

    Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs

    Measured: From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2

  3. Duration of response (DoR)

    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.

    Measured: To be assessed up to approximately 5 years.

  4. Complete response (CR) rate (central review)

    Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.

    Measured: To be assessed up through study completion, up to approximately 5 years

  5. Complete response (CR) rate (investigator assessment)

    Complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.

    Measured: To be assessed up through study completion, up to approximately 5 years

  6. Overall response rate (ORR) (investigator assessment)

    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.

    Measured: 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.

  7. Duration of complete response (DoCR)

    Defined as the time from achievement of complete response (CR) to relapse or death due any cause, as assessed by central review

    Measured: To be assessed up to approximately 5 years.

  8. Time to response (TTR)

    Defined as the time from first dose until first documented objective response, as assessed by central review.

    Measured: From the first dose until the first objective response, up to approximately 5 years.

  9. Event-free survival (EFS)

    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.

    Measured: To be assessed up to approximately 5 years

  10. Progression-free survival (PFS)

    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.

    Measured: To be assessed up to approximately 5 years.

  11. Time to next anti-lymphoma (TTNT)

    Defined as time from first dose until the start date of subsequent anti-lymphoma therapy or death due to any cause.

    Measured: To be assessed up to approximately 5 years.

  12. Overall survival (OS)

    Defined as the time from first dose until the date of death due to any cause.

    Measured: To be assessed up to approximately 5 years.

  13. Plasma concentrations of surovatamig

    To characterize the plasma concentration of surovatamig as monotherapy

    Measured: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment

  14. Area under the concentration time curve (AUC)

    To characterize the pharmacokinetics (PK) AUC of surovatamig as monotherapy

    Measured: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment

  15. Maximum plasma concentration (Cmax)

    To characterize the pharmacokinetics (PK) (Cmax) of surovatamig as monotherapy

    Measured: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment

  16. Time to maximum plasma concentration (Tmax)

    To characterize the pharmacokinetics (PK) (Tmax) of surovatamig as monotherapy

    Measured: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment

  17. A trough concentration (Cthrough)

    To characterize the pharmacokinetics (PK) (C through) of surovatamig as monotherapy

    Measured: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment

  18. Immunogenecity of surovatamig

    The number and percentage of participants who develop Anti-Drug Antibodies (ADAs)

    Measured: 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)

  19. Change from baseline in EORTC IL233 scales

    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).

    Measured: To be assessed up through study completion, up to approximately 5 years

  20. Change from baseline in PGI-TT scale

    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"

    Measured: To be assessed up through study completion, up to approximately 5 years

  21. Change from baseline in EORTC IL 232 QL2 scores

    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.

    Measured: To be assessed up through study completion, up to approximately 5 years

  22. Change from baseline in FACT-LymS scales

    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).

    Measured: To be assessed up through study completion, up to approximately 5 years

  23. Minimal residual disease (MRD)

    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.

    Measured: To be assessed up through study completion, up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2024
  2. Study start27 Nov 2024
  3. Primary completion21 Apr 2028 (estimated)
  4. Study completion21 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526793
Sponsor's protocol ID
D7404C00001
Other IDs
2023-505789-27-00, 2023
Acronym
SOUNDTRACK-B
Status last verified
Oct 2026
First submitted
3 Jul 2024
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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

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