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.
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
- Conditions the study is for
- B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma (FL), Large B-Cell Lymphoma (LBCL)
- 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
- 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.
- 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
94 sites in 16 countries
United States23 sites, 16 recruiting
- 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
- Withdrawn
Research Site
Iowa City, Iowa, 52242
- Withdrawn
Research Site
Jacksonville, Florida, 32224
- Recruiting
Research Site
Milwaukee, Wisconsin, 53226
- Recruiting
Research Site
Nashville, Tennessee, 37203
- Withdrawn
Research Site
New Brunswick, New Jersey, 08901
- Recruiting
Research Site
New York, New York, 10016
- Withdrawn
Research Site
Overland Park, Kansas, 66204
- Recruiting
Research Site
Philadelphia, Pennsylvania, 19104
- Withdrawn
Research Site
Phoenix, Arizona, 85054
- Recruiting
Research Site
Pittsburgh, Pennsylvania, 15232
- Withdrawn
Research Site
Pittsburgh, Pennsylvania, 15232
- Recruiting
Research Site
Portland, Oregon, 97239
- Recruiting
Research Site
Rochester, Minnesota, 55905
- Recruiting
Research Site
San Antonio, Texas, 78229
- Withdrawn
Research Site
St Louis, Missouri, 63110
- Recruiting
Research Site
Tampa, Florida, 33612
- Recruiting
Research Site
Waukee, Iowa, 50263
China11 sites, 11 recruiting
- 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
Japan8 sites, 8 recruiting
- 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
Italy6 sites, 5 recruiting
- 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
- Withdrawn
Research Site
Roma, 161
Taiwan6 sites, 5 recruiting
- Withdrawn
Research Site
Kaohsiung City, 80756
- Recruiting
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
Germany5 sites, 5 recruiting
- 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
South Korea5 sites, 5 recruiting
- 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
United Kingdom5 sites, 5 recruiting
- 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
Australia4 sites, 4 recruiting
- Recruiting
Research Site
Heidelberg, 3084
- Recruiting
Research Site
Kogarah, NSW 2217
- Recruiting
Research Site
Macquarie University, 2109
- Recruiting
Research Site
Nedlands, 6009
Canada4 sites, 3 recruiting
- Withdrawn
Research Site
Barrie, Ontario, L4M 6M2
- Recruiting
Research Site
Brampton, Ontario, L6R 3J7
- Recruiting
Research Site
Ottawa, Ontario, K1H 8L6
- Recruiting
Research Site
Toronto, Ontario, M5G 2M9
France4 sites, 4 recruiting
- Recruiting
Research Site
Montpellier, 34295
- Recruiting
Research Site
Paris, 75010
- Recruiting
Research Site
Pierre-Bénite, 69495
- Recruiting
Research Site
Rouen, 76038
Brazil3 sites
- Withdrawn
Research Site
Porto Alegre, 90035903
- Active, not recruiting
Research Site
São Paulo, 01401-002
- Active, not recruiting
Research Site
São Paulo, 05652-900
Denmark3 sites, 2 recruiting
- Withdrawn
Research Site
Aalborg, 9100
- Recruiting
Research Site
Copenhagen, 2100
- Recruiting
Research Site
Vejle, 7100
Spain3 sites, 3 recruiting
- Recruiting
Research Site
Barcelona, 08035
- Recruiting
Research Site
Madrid, 28040
- Recruiting
Research Site
Pozuelo de Alarcón, 28223
Hong Kong2 sites, 2 recruiting
- Recruiting
Research Site
Hong Kong, 999077
- Recruiting
Research Site
Shatin
Sweden2 sites, 2 recruiting
- Recruiting
Research Site
Gothenburg, 41345
- Recruiting
Research Site
Stockholm, 17176
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 group | Role | What they receive |
|---|---|---|
| Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma | Experimental | 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. Receives: Drug: Surovatamig |
| Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL | Experimental | 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. Receives: Drug: Surovatamig |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
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
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
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.
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.
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.
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
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.
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.
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.
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
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
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
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
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
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)
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
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
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
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
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.
- First posted30 Jul 2024
- Study start27 Nov 2024
- Primary completion21 Apr 2028 (estimated)
- Study completion21 Oct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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