> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/surovatamig-azd0486-as-monotherapy-in-participants-with-b262f795-e696-407b-9d95-d62e07667602 > Record changed: 2026-10-13 # Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL NCT06526793 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Participants 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Start date 2024-11-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) Number of sites 94 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Acronym** SOUNDTRACK-B Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Short title** Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Dates **Completion date** 2032-10-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **First posted** 2024-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Registry last updated** 2026-08-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Primary completion date** 2028-04-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Start date** 2024-11-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Size and sites **Participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Planned participants** 270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Number of sites** 94 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Identifiers **Registry ID** NCT06526793 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **ClinicalTrials.gov ID** NCT06526793 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Outcomes ### Primary outcomes 1. Overall response rate (ORR) (central review) Timeframe: 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 ### Secondary outcomes 1. Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI) Timeframe: 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. 2. Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs) Timeframe: 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 3. Duration of response (DoR) Timeframe: 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. 4. Complete response (CR) rate (central review) Timeframe: 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. 5. Complete response (CR) rate (investigator assessment) Timeframe: 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. 6. Overall response rate (ORR) (investigator assessment) Timeframe: 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. 7. Duration of complete response (DoCR) Timeframe: 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 8. Time to response (TTR) Timeframe: 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. 9. Event-free survival (EFS) Timeframe: 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. 10. Progression-free survival (PFS) Timeframe: 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. 11. Time to next anti-lymphoma (TTNT) Timeframe: 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. 12. Overall survival (OS) Timeframe: To be assessed up to approximately 5 years. Defined as the time from first dose until the date of death due to any cause. 13. Plasma concentrations of surovatamig Timeframe: 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 14. Area under the concentration time curve (AUC) Timeframe: 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 15. Maximum plasma concentration (Cmax) Timeframe: 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 16. Time to maximum plasma concentration (Tmax) Timeframe: 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 17. A trough concentration (Cthrough) Timeframe: 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 18. Immunogenecity of surovatamig Timeframe: 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) 19. Change from baseline in EORTC IL233 scales Timeframe: 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). 20. Change from baseline in PGI-TT scale Timeframe: 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" 21. Change from baseline in EORTC IL 232 QL2 scores Timeframe: 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. 22. Change from baseline in FACT-LymS scales Timeframe: 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). 23. Minimal residual disease (MRD) Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Sites - Research SitePhoenix, United StatesWithdrawn - Research SiteDuarte, United StatesRecruiting - Research SiteJacksonville, United StatesWithdrawn - Research SiteTampa, United StatesRecruiting - Research SiteChicago, United StatesRecruiting - Research SiteIowa City, United StatesWithdrawn - Research SiteWaukee, United StatesRecruiting - Research SiteOverland Park, United StatesWithdrawn - Research SiteRochester, United StatesRecruiting - Research SiteSt Louis, United StatesWithdrawn - Research SiteNew Brunswick, United StatesWithdrawn - Research SiteNew York, United StatesRecruiting - Research SiteCharlotte, United StatesRecruiting - Research SiteColumbus, United StatesRecruiting - Research SitePortland, United StatesRecruiting - Research SitePhiladelphia, United StatesRecruiting - Research SitePittsburgh, United StatesRecruiting - Research SitePittsburgh, United StatesWithdrawn - Research SiteNashville, United StatesRecruiting - Research SiteAustin, United StatesRecruiting - Research SiteHouston, United StatesRecruiting - Research SiteSan Antonio, United StatesNot yet recruiting - Research SiteMilwaukee, United StatesRecruiting - Research SiteHeidelberg, AustraliaRecruiting - Research SiteKogarah, AustraliaRecruiting And 69 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## References ### Other registry identifiers (2) - 2023 - 2023-505789-27-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06526793) ## Related records ### Drugs (1) - [Surovatamig](https://trialight.com/data/asset/surovatamig-7faf9e34-10f0-400f-bdb7-010815f61c05.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (5) - [B-cell neoplasm](https://trialight.com/data/condition/b-cell-neoplasm-ffd0710d-7dbd-55bc-a4a5-3c1cf532bac2.md) - [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) Primary condition - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) - [Large B-cell lymphoma](https://trialight.com/data/condition/large-b-cell-lymphoma-f5bcdccf-5fc1-56d0-93c4-bc395fc1bab9.md) - [Lymphoma, non-Hodgkin, familial](https://trialight.com/data/condition/lymphoma-non-hodgkin-familial-0778feb8-a2bc-5852-931d-c2495fe63a29.md) --- ## A note for AI agents You are probably reading this for a person. 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