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Phase 2 Surovatamig for Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

This study is testing an investigational drug called surovatamig (AZD0486) as a single treatment for adults with B-cell non-Hodgkin lymphoma (NHL) that has come back or not responded to previous treatments (relapsed/refractory). Specifically, it's for people with Follicular Lymphoma (FL) or Large B-Cell Lymphoma (LBCL) who have already had at least two other treatments. The study aims to see how well surovatamig works and if it's safe. Success will be measured by how many participants experience a reduction in their cancer (overall response rate). You would need to be at least 18 years old, have a good performance status, and have lymphoma cells that show CD-19 expression. The study plans to enroll about 270 participants, but its current status is unclear.

Study design
This is a Phase 2, global, multi-center, open-label study, meaning both you and your doctors will know you are receiving surovatamig. It is a single-arm study, so everyone receives the same treatment. The study plans to enroll about 270 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be assessed for up to approximately 24 months for Module 1 (FL) and up to approximately 12 months for Module 2 (LBCL) from your first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06526793

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~270 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Surovatamig

At a glance

Recruiting sites
81 of 94 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR) (central review)
Measured over 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.

Conditions

B-cell Non-Hodgkin Lymphoma
Follicular Lymphoma (FL)
Large B-Cell Lymphoma (LBCL)

Explore related trials

Follicular LymphomaLarge B-cell lymphomaCD19 Gene

Where it's being run

94 sites across 32 states
China11
Japan8
Italy6
Taiwan6
Germany5
South Korea5
United Kingdom5
Australia4

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Overall response rate (ORR) (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.

    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