SUROVATAMIG (human IgG4 kappa monoclonal antibody against CD3 and CD19) for Large B-cell Lymphoma

Inclusion criteria

• {"criterion_text":"- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment\n- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma\n- FDG-avid and measurable disease as per Lugano and Ann Arbor staging\n- Stage I bulky (7.5 cm and greater) to Stage IV\n- ECOG performance status 0 to 2\n- Adequate bone marrow, liver, renal and cardiac function.\n- The above is a summary, other inclusion criteria details may apply."}

Exclusion criteria

• {"criterion_text":"- As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol\n- Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter’s transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).\n- History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition\n- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).\n- Active or uncontrolled infection\n- Major cardiac abnormalities\n- Prior anti-lymphoma therapy except for corticosteroids for symptom control\n- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions\n- The above is a summary, other exclusion criteria details may apply"}

Primary endpoints

• {"endpoint_text":"- Safety Run in: Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest;","definition_or_measurement_approach":"Incidence and severity of adverse events, serious adverse events, adverse events of special interest and events of clinical interest (as collected/reported per protocol during the Safety Run in)."}
• {"endpoint_text":"- Safety Run in: AEs/AEs leading to discontinuation or dose modification of AZD0486","definition_or_measurement_approach":"Adverse events and adverse events leading to discontinuation or dose modification of AZD0486 (as recorded per protocol during the Safety Run in)."}
• {"endpoint_text":"- Safety Run in: Clinically significant alterations in vital signs and abnormal laboratory parameters","definition_or_measurement_approach":"Clinically significant changes in vital signs and abnormal laboratory parameters assessed during the Safety Run in per protocol-defined criteria."}
• {"endpoint_text":"- Phase 3: PFS defined as the time from date of randomisation until disease progression as per Lugano 2014 as assessed by BICR, or death due to any cause","definition_or_measurement_approach":"PFS = time from randomisation until disease progression per Lugano 2014 assessed by Blinded Independent Central Review (BICR), or death from any cause."}

Secondary endpoints

• {"endpoint_text":"- Safety Run in: ORR, CR Rate, DoR, DoCR, PFS, OS","definition_or_measurement_approach":"Overall response rate (ORR), complete response (CR) rate, duration of response (DoR), duration of complete response (DoCR), progression-free survival (PFS), overall survival (OS) as defined in protocol for Safety Run in."}
• {"endpoint_text":"- Safety Run in: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP","definition_or_measurement_approach":"Pharmacokinetic measurements: serum concentration and PK parameters of AZD0486 following R-mini-CHOP as data permits."}
• {"endpoint_text":"- Safety Run in: Summary of pre-existing and treatment induced ADAs for AZD0486 and the impact on PK, efficacy or safety","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADA) pre-existing and treatment-induced and their impact on PK, efficacy or safety for AZD0486."}
• {"endpoint_text":"- Phase 3: OS","definition_or_measurement_approach":"Overall survival measured from randomisation to death from any cause."}
• {"endpoint_text":"- Phase 3: ORR, CR rate, DoR, DoCR, PFS, PFS2, TFST","definition_or_measurement_approach":"Efficacy endpoints including ORR, CR rate, DoR, DoCR, PFS, second progression-free interval (PFS2), time to first subsequent therapy (TFST) as defined in protocol."}
• {"endpoint_text":"- Phase 3: AEs, SAEs, AESIs, events of clinical interest, AEs leading to study treatment discontinuation or dose modification","definition_or_measurement_approach":"Safety endpoints including adverse events, serious adverse events, adverse events of special interest, clinical events of interest, and AEs leading to treatment discontinuation or dose modification, collected per protocol."}
• {"endpoint_text":"- Phase 3: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP","definition_or_measurement_approach":"PK endpoints: serum concentration and pharmacokinetic parameters of AZD0486 following R-mini-CHOP as data permits."}
• {"endpoint_text":"- Phase 3: Summary of pre-existing and treatment induced ADAs for AZD0486 (positive or negative, titres) and the impact on PK, efficacy or safety","definition_or_measurement_approach":"Summary and titration of ADAs (pre-existing and treatment induced) for AZD0486 and their impact on PK, efficacy, or safety."}
• {"endpoint_text":"- Phase 3: eCOA: - Proportion reporting different levels of pain and tirednesswhile on treatment using items from the FACT-LymS subsetfor all dosed participants","definition_or_measurement_approach":"Electronic clinical outcome assessments (eCOA) using FACT-LymS subset items to record proportions reporting different levels of pain and tiredness while on treatment."}
• {"endpoint_text":"- Phase 3: eCOA: - Proportion reporting each level of overall side effect bother on the PGI-TT, while on treatment for all dosed participants","definition_or_measurement_approach":"eCOA: proportion reporting each level of overall side effect bother on the PGI-TT during treatment for all dosed participants."}
• {"endpoint_text":"- Phase 3: eCOA: - Change from baseline on lymphoma-specific concerns based on FACT-LymS scores for all randomised participants","definition_or_measurement_approach":"eCOA: change from baseline in lymphoma-specific concerns measured by FACT-LymS scores for all randomised participants."}
• {"endpoint_text":"- Phase 3: eCOA: - Change from baseline on overall HRQoL (based on QL2 item scores) for all randomised participants","definition_or_measurement_approach":"eCOA: change from baseline in overall health-related quality of life based on QL2 item scores for all randomised participants."}

Poland

Earliest CTIS Part Ii Submission Date

20-01-2026

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

50

Number Of Sites

5

Number Of Participants

16

Belgium

Earliest CTIS Part Ii Submission Date

08-01-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

104

Number Of Sites

7

Number Of Participants

14

Primary sponsor

Full Name

AstraZeneca AB

Organisation Type

Pharmaceutical company

Country Of Registered Address

Sweden