고형암 대상 CAR-T 치료제 임상시험의 유효성, 안전성에 대한 체계적 문헌고찰 및 메타분석

초록

The clinical efficacy and safety of chimeric antigen receptor T-cell (CAR-T) therapy for solid tumors remain uncertain due to heterogeneity in targets and therapeutic strategies across studies. This study conducted a systematic review and metaanalysis to assess the clinical benefit rate and adverse events associated with CAR-T therapy in patients with solid tumors. A comprehensive literature search was performed in PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials for studies published up to October 12, 2024, following Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Studies were selected based on the Population, Intervention, Comparison, and Outcome framework. The quality assessment was conducted using the Risk Of Bias In Non-randomised Studies - of Interventions (ROBINS-I) tool for evaluating bias in non-randomized studies, and statistical analyses were performed with R software The primary outcomes were clinical benefit rate (CBR) and adverse event incidence. Meta-analysis of 19 studies showed a pooled CBR of 67% (95% CI: 58–75%). Subgroup analysis by target antigen showed that the clinical benefit rate (CBR) ranged from 49% to 74%, with CLDN18.2 demonstrating the highest CBR at 74% (95% CI: 17–98%). The incidence of grade 1–2 cytokine release syndrome was 48% (95% CI: 30–66%), and other reported toxicities included gastrointestinal, hematologic, systemic, neurologic events, and immune effector cell-associated neurotoxicity syndrome. These findings highlight the therapeutic potential of CAR-T cell therapy in solid tumors and suggest that careful selection of target antigens and monitoring for specific adverse events are essential for future clinical trial design and implementation. (PeRM 2025;17:187-197)

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