Meta-analysis of treatment-related adverse events of CD3-based T cell-engaging bispecific antibodies in patients with cancer
As CD3-based T cell-engaging bispecific antibodies for cancer therapy enter practice, it is essential to systematically characterize the range of treatment-related adverse events (TRAEs) associated with these antibodies. Researchers from Central South University (Changsha, China) conducted a meta-analysis of studies published up to August 2025 to summarize these TRAEs. The meta-analysis included 104 trials enrolling 10 353 patients (7311 with hematologic malignancies and 3042 with solid tumors). For hematologic malignancies, the overall incidence of all-grade TRAEs was 97.5% (95% CI 95.2-98.7; I2 88.2%) and of grade 3 or worse TRAEs 70.3% (62.6-77.0; 94.4). For solid tumors, corresponding incidences were 97.9% (95% CI 95.7-99.0; I2 57.0%) and 45.3% (38.4-52.4; 87.0). Treatment-related deaths occurred in 1.0% (95% CI 0.8-1.3; I2 0.0%). The predominant causes were sepsis, pneumonia, neutropenic infection, respiratory failure, septic shock, and multi-organ failure. The authors conclude that the toxicity profile of T cell-engaging bispecific antibodies varies substantially across cancer types and antibody classes.