Document Type
Article
Publication Date
5-8-2026
Abstract
BACKGROUND: T-cell redirecting therapies, including T-cell engagers (TCEs) and Chimeric Antigen Receptor T-cell (CAR-T), are under investigation in metastatic castration-resistant prostate cancer (mCRPC). Despite their promising therapeutic potential, these therapies remain in early stages of development due to treatment-related adverse events (TRAEs). This study aims to quantify the frequency and severity of adverse events in clinical trials with a pooled analysis.
MATERIALS AND METHODS: A systematic search of PubMed, CINHAL, Scopus, and Ovid was conducted to identify clinical trials evaluating TCEs or CAR-T in patients with mCRPC. Types and frequencies of TRAEs were collected and analyzed using a random-effects model.
RESULTS: Thirteen TCEs trials involving 861 patients and 5 CAR-T trials involving 55 patients were identified. Cytokine release syndrome occurred in 59% (95% confidence interval: 25, 86) and 43% (28, 59) with TCEs and CAR-T, respectively. Neurologic TRAEs occurred in 39% (22, 60) with CAR-T compared to 9% (4, 17) with TCEs (P < 0.0001). Hematologic and hepatic TRAEs occurred in 34% (8, 75) and 25% (12, 44) with CAR-T, compared to 23% (7, 56) and 33% (12, 64) with TCEs, respectively. Musculoskeletal/dermatologic TRAEs occurred in 33% (24, 42) and 29% (8, 58) with TCEs and CAR-T, respectively. Renal and gastrointestinal TRAEs occurred in 21% (5, 51) and 14% (2, 43) with CAR-T, compared to 15% (8, 25) and 21% (12, 36) with TCEs, respectively.
CONCLUSIONS: These data underscore the TRAE profiles associated with these therapies and emphasize the importance of differentiating off-target toxicities from immune effector cell-toxicities to inform the development of effective TRAE mitigation strategies.
Recommended Citation
Saxena, Abhiraj; Yorker, Marc; Zorko, Nicholas; Narayan, Vivek; Siddiqui, Bilal; Saraiya, Biren; Tester, William; Mille, Patrick; Shaver, Amy; Nikita, Nikita; Lu-Yao, Grace; Kelly, W. Kevin; and Zarrabi, Kevin K., "Prevalence of Adverse Events Following T-Cell Redirecting Therapies in Patients With Metastatic Castration-Resistant Prostate Cancer: A Pooled Analysis" (2026). Department of Medical Oncology Faculty Papers. Paper 342.
https://jdc.jefferson.edu/medoncfp/342
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.
PubMed ID
42081291
Language
English
Comments
This article is the author’s final published version in Oncologist, Volume 31, Issue 6, 2026, Article number oyag172.
The published version is available at https://doi.org/10.1093/oncolo/oyag172. Copyright © The Author(s) 2026.