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The following is a summary of “Safety and efficacy of amulirafusp alfa (IMM0306), a fusion protein of CD20 monoclonal antibody with the CD47 binding domain of SIRPα, in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: a phase 1/2 study,” published in the December 2024 issue of Hematology by Yang et al. 

Amulirafusp alfa (IMM0306) is a fusion protein of signal-regulatory protein alpha (SIRPα) CD47 binding domain and CD20 monoclonal antibody. It targets B-cell non-Hodgkin lymphoma (B-NHL). 

Researchers conducted a prospective study to evaluate the safety and preliminary efficacy of amulirafusp alfa in relapsed or refractory (R/R) B-NHL. 

They enrolled patients with CD20 + R/R B-NHL who had received at least 2 prior therapies. Patients received a single dose of amulirafusp alfa in the first 2 weeks, followed by weekly intravenous doses in 4-week cycles. The primary endpoints were to assess safety, determine the maximum tolerated dose (MTD), and establish the recommended phase 2 dose (RP2D). 

The results showed that between May 22, 2020, and February 10, 2022, 48 patients with R/R B-NHL received amulirafusp alfa at doses of 40–2,000 μg/kg. No dose-limiting toxicity (DLT) was observed, and the MTD was not reached. The RP2D was 2000 μg/kg. All grades of treatment-related adverse events (TRAEs) occurred in 48 (100%) patients, and ≥grade 3 TRAEs in 33 (68.8%) patients. The most common ≥grade 3 TRAEs were decreased lymphocyte count (58.3%), white blood cell (WBC) count (20.8%), neutrophil count (18.8%), and anemia (10.4%). At doses of 800–2000 μg/kg, the objective response rate in follicular lymphoma was 41.2% (7/17, 95% confidence interval [CI] 18.4–67.1), and in marginal zone lymphoma (MZL) was 33.3% (2/6, 95% CI 3.7–71.0), respectively. 

Investigators noticed that amulirafusp alfa showed a favorable safety profile and preliminary efficacy in R/R B-NHL, warranting further study. 

Source: jhoonline.biomedcentral.com/articles/10.1186/s13045-024-01646-2