AZD0486 in B-Cell ALL: SYRUS Study – Safety & Dosing
- Milan, Italy-Early findings from the SYRUS study suggest that AZD0486 could be a promising treatment for adolescent and adult patients battling relapsed or refractory B-cell acute lymphoblastic leukemia...
- The phase 1/2 SYRUS study (NCT06137118) focuses on evaluating the safety and efficacy of AZD0486, a novel IgG fully human CD3/CD19 bispecific T-cell engager.
- Prior research explored AZD0486 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, demonstrating both activity and tolerability in follicular lymphoma and diffuse large B-cell lymphoma.
Early results from the SYRUS study highlight the potential of AZD0486, a novel bispecific T-cell engager, as a treatment for relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). The research, presented at the EHA 2025 congress, indicates promising safety and tolerability profiles, making AZD0486 a focal point in ALL treatment. This phase 1/2 study explores the efficacy,pharmacokinetics,and immunogenicity of AZD0486,focusing on a dose escalation strategy with three parts: dose escalation,optimization,and expansion. news Directory 3 provides insights into the study’s structure and findings, including the triple-step-up dosing approach. Explore the data from the first three dose levels. discover what’s next …
AZD0486 Trial Shows promise for B-Cell Acute Lymphoblastic Leukemia
Milan, Italy-Early findings from the SYRUS study suggest that AZD0486 could be a promising treatment for adolescent and adult patients battling relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). Dr. Ibrahim Aldoss, an associate professor at City of Hope, presented thes initial results at the European Hematology Association (EHA) 2025 Congress.
The phase 1/2 SYRUS study (NCT06137118) focuses on evaluating the safety and efficacy of AZD0486, a novel IgG fully human CD3/CD19 bispecific T-cell engager. This innovative therapy is designed with a low-affinity CD3 binding site to minimize cytokine release syndrome (CRS) and a silent IgG4 Fc tail, extending it’s half-life to 12 to 15 days.
Prior research explored AZD0486 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, demonstrating both activity and tolerability in follicular lymphoma and diffuse large B-cell lymphoma. The SYRUS study specifically investigates AZD0486’s potential in treating B-cell ALL.
The primary goal of the dose escalation phase of the SYRUS study was to assess the safety and tolerability of AZD0486.Secondary objectives included evaluating efficacy, pharmacokinetics (PK), and immunogenicity. The study is structured into three parts: dose escalation (Part A), dose optimization (Part B), and dose expansion (Part C).
During the EHA Congress, Aldoss presented data from the frist three dose levels of Part A.The AZD0486 treatment involved a triple-step-up dosing approach,with doses increasing on days 1,4,and 8,and the target dose administered on day 15,followed by intravenous infusions every two weeks.
The study evaluated AZD0486 at three dose levels, with varying step-up dosing. The target doses were 2.4 mg (dose level 1), 7.2 mg (dose level 2), and 15 mg (dose level 3). Key eligibility criteria included patients aged 16 and older with relapsed or refractory B-cell ALL expressing CD19, who had failed at least two prior lines of therapy. Prior exposure to CD19-targeted therapies was permitted.
What’s next
Further research will focus on dose optimization and expansion to determine the recommended phase 2 dosing for AZD0486 in treating B-cell acute lymphoblastic leukemia and to further assess the safety and efficacy of this novel therapy.