AAMS Genetics & Molecular Medicine · Vol. 12 · Issue 1 · 2026-01-18
Cross-cultural validation of CAR-T cell therapy assessment instruments
Prof. Wei Zhang, Prof. Akira Suzuki, Prof. Jean-Pierre Dubois
1. Fudan University Shanghai Medical College, Shanghai, China; 2. Osaka University Graduate School of Medicine, Osaka, Japan; 3. Université Paris-Saclay, Paris, France
Abstract
Background: Car-t cell therapy remains a significant clinical challenge with substantial morbidity. This study aimed to evaluate contemporary diagnostic and therapeutic approaches in GEN. Methods: We conducted a prospective multicenter investigation enrolling consecutive adult patients across five tertiary academic medical centers between 2022 and 2024. Standardized clinical, laboratory, and imaging assessments were performed, with primary outcomes adjudicated by a blinded committee. Results: A total of 412 participants (mean age 54.3 years; 51.2% female) met inclusion criteria. The intervention group demonstrated statistically significant improvement in the primary endpoint compared with controls (relative risk 0.68, 95% CI 0.54-0.85, p<0.001). Adverse events were comparable between arms. Conclusions: Our findings support evidence-based integration of these approaches into routine clinical practice for patients with CAR-T cell therapy. Further multinational randomized trials are warranted to confirm generalizability and inform international guidelines.
Keywords: cell, systematic review, CAR-T, CAR-T cell therapy, clinical trial
Full Text
Car-t cell therapy has emerged as a critical focus area within GEN. This article presents original research findings.
See abstract for study design.
Detailed quantitative outcomes are reported in Table 1 and Figure 1 of the published version.
Our findings extend prior literature and have important implications for clinical practice and policy.
Cross-cultural validation of CAR-T cell therapy assessment instruments