Evaluation of the Efficacy and Safety of Chimeric Antigen Receptor-Modified T (CAR-T) Cell Therapy in Leukemia: A Five-Year Updated Systematic Review and Meta-analysis

I Gede Wikania Wira Wiguna, I Gede Krisna Arim Sadeva, Christo Timothy Mamangdean, Putu Mirah Wahyu Subagia Putri, Kadek Meryndha Kumala Tungga, I Komang Raditya Putra Pratama, Agung Brahmanthya Nadine Kepakisan, Komang Indra Parama Arta, Putu Ari Shanti Dewi, I Gede Putu Supadmanaba, Desak Made Wihandani

Abstract

Objective: Despite the progress made by conventional treatments in reducing mortality rates, the significant number of relapsed or refractory patients necessitates the exploration of novel therapies. Recent studies on chimeric antigen receptor T-cell therapy (CAR-T) cells have shown promising outcomes for individuals battling blood cancers. However, the outcomes are still inconsistent due to the structural complexity of CAR-T cells and the rapid development of more advanced versions. This study evaluated the efficacy and safety of various CAR-T cells in Leukemia patients. 
Material and Methods: The preferred reporting items for systematic reviews and meta-analysis 2020 protocol was used for the literature search and systematic review. Studies reporting CAR-T cell therapy’s efficacy and safety in Leukemia patients were included. Statistical analyses were performed using R statistical software v.3.3. P-values≤0.05 were considered statistically significant. 
Results: Eighteen single-arm clinical trials were included based on the inclusion criteria. Most of the studies involved patients with acute Lymphoblastic Leukemia. CAR-T cell therapy in Leukemia achieved a 79% (95% confidence interval [CI] [69%-87%], I2=74%) complete response, 79% (95% CI [59%-91%], I2=87%) cytokine release syndrome event, 18% (95% CI [9%-33%], I2=72%) immune effector cell-associated neurotoxicity syndrome event rate, 69% (95% CI [47%-85%], I2=82%) minimal residual disease-negative, and a 9% (95% CI [8%-13%], I2=37%) mortality rate.
Conclusion: CAR-T therapy has demonstrated efficient responses in Leukemia patients, reinforcing the positive outcomes observed with favorable toxicities. Further data regarding the durability of CAR-T cell therapy are essential for strengthening our understanding of CAR-T cell efficacy and safety in Leukemia patients.

 

 Keywords

CAR-T cell therapy; efficacy; Leukemia; safety

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DOI: http://dx.doi.org/10.31584/jhsmr.20251201

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