A Phase 2 interventional study of Surovatamig in B-cell Non-Hodgkin Lymphoma, Follicular Lymphoma (FL) and Large B-Cell Lymphoma (LBCL), sponsored by AstraZeneca. Recruiting at 94 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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.
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.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 270 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Adequate hematological function: ≥ 1000/mm3,
The above is a summary, other inclusion criteria details may apply.
Key Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Surovatamig
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.
Drug: Surovatamig
Investigational Product administered via intravenous infusion.
Also known as: AZD0486
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
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.
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: To be assessed up to approximately 5 years.
Plasma concentrations of surovatamig
To characterize the plasma concentration of surovatamig as monotherapy
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
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)
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).
Time frame: 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"
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: To be assessed up through study completion, up to approximately 5 years
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Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan
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
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
Data sharing details ↗ · vivli.org
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Started Nov 2024 (actual). Primary completion is estimated for Apr 2028, 40 months after the start.
Of 122 phase 2 interventional studies under Lymphoma, B-Cell, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 77. This study's planned 40 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Surovatamig