Surovatamig

• What is surovatamig?
• How does surovatamig work?
• Which conditions is it studied for?
• How is surovatamig given?
• What do the clinical trials show?
• What side effects are known?

What is surovatamig?

Surovatamig (also known as AZD0486) is an investigational bispecific antibody. It is a protein-based substance, specifically a humanised bispecific monoclonal antibody that targets both CD3 on T cells and CD19 on B cells.^[8] The substance is being developed by AstraZeneca AB and has no marketing authorisation in the product records, meaning it is not yet available as an approved medicine.^[4]

Surovatamig has received orphan designation for the treatment of follicular lymphoma in the European Union on 9 January 2026 and in the United States on 20 February 2026.^[7][6] Orphan designation does not mean the medicine is authorised for use; it provides regulatory support to the developer during development.^[7]

How does surovatamig work?

Surovatamig is a bispecific antibody, meaning it can bind to two different targets at the same time. One arm binds to CD3, a protein found on T cells, and the other arm binds to CD19, a protein found on B cells.^[8] By bringing T cells and B cells together, surovatamig is designed to help the immune system recognise and attack B cells, including cancerous B cells in conditions such as B-cell lymphomas and leukaemias.^[8]

Which conditions is it studied for?

• Relapsed or refractory non-Hodgkin lymphoma — a Phase 2 trial is testing surovatamig in adults whose B-cell non-Hodgkin lymphoma has come back or not responded to previous treatment.^[4]
• B-cell acute lymphoblastic leukaemia (B-ALL) — a Phase 1 trial is studying surovatamig in people aged 12 years and above with relapsed or refractory B-ALL.^[3]
• Chronic lymphocytic leukaemia and small lymphocytic lymphoma — a Phase 1 trial is testing surovatamig alone or in combination with other anticancer drugs in these conditions.^[5]
• Large B-cell lymphoma and mantle cell lymphoma — the same Phase 1 trial includes these B-cell malignancies.^[5]
• Large B-cell lymphoma in older or unfit adults — a Phase 3 trial is comparing surovatamig after R-mini-CHOP with R-mini-CHOP alone.^[1]
• Antibody-mediated kidney disease — a Phase 2 trial is studying surovatamig in adults with this condition, focusing on its effect on protein in the urine.^[2]
• Follicular lymphoma — surovatamig has orphan designation for this condition, although no registered trial specifically in follicular lymphoma is listed here.^[7]

How is surovatamig given?

In the registered trials, surovatamig is given as a solution for infusion into a vein (intravenous use).^[4] Some trials also include subcutaneous administration, where the drug is injected under the skin.^[5] The Phase 3 trial in large B-cell lymphoma uses a 25 mg dose of surovatamig given intravenously.^[1]

What do the clinical trials show?

Five clinical trials of surovatamig are currently listed as authorised. The conditions studied include several types of B-cell blood cancer and one non-cancer condition, antibody-mediated kidney disease. The trials are in different phases, from early safety testing to a Phase 3 trial comparing surovatamig with standard treatment.

What phases and status are the trials in?

• One Phase 3 trial in large B-cell lymphoma, with 420 planned participants.^[1]
• Two Phase 2 trials: one in relapsed or refractory non-Hodgkin lymphoma with 270 participants, and one in antibody-mediated kidney disease with 34 participants.^[4][2]
• Two Phase 1 trials: one in several B-cell malignancies with 446 participants, and one in B-cell acute lymphoblastic leukaemia with 371 participants.^[5][3]

All five trials are listed as authorised, meaning they have received approval to begin but may not yet be recruiting participants.

What are the trials measuring?

The Phase 2 trial in non-Hodgkin lymphoma measures the objective response rate (ORR), which is the proportion of participants whose cancer shrinks or disappears, based on Lugano 2014 response criteria and assessed by an independent review committee.^[4] The Phase 3 trial in large B-cell lymphoma measures progression-free survival (PFS), defined as the time from randomisation until the disease progresses or death from any cause.^[1] The Phase 1 trials focus mainly on safety, including the incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory values and vital signs.^[5][3] The Phase 2 trial in antibody-mediated kidney disease measures safety outcomes and the change in protein in the urine (UPCR) at 6 months.^[2]

Who can take part in these trials?

Eligibility varies by trial. The Phase 2 trial in non-Hodgkin lymphoma is for adults with relapsed or refractory B-cell non-Hodgkin lymphoma.^[4] The Phase 1 trial in B-ALL includes people aged 12 years and above with relapsed or refractory B-cell acute lymphoblastic leukaemia.^[3] The Phase 3 trial is specifically for older or physically weak (unfit) adults with large B-cell lymphoma.^[1] The Phase 1 combination trial includes adults with several mature B-cell malignancies, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, large B-cell lymphoma, and mantle cell lymphoma.^[5] The Phase 2 kidney disease trial is for adults with antibody-mediated kidney disease.^[2]

What side effects are known?

The available sources do not provide detailed information on side effects of surovatamig. The registered trials are designed to measure the incidence and severity of adverse events and serious adverse events, including dose-limiting toxicities and adverse events of special interest.^[5][1] Specific side effects will be reported as the trials progress.