Evaluation of the safety and efficacy of humanized anti-CD19 chimeric antigen receptor T-cell therapy in older patients with relapsed/refractory diffuse large B-cell lymphoma based on the comprehensive geriatric assessment system

Abstract

Anti-CD19 chimeric antigen receptor (CAR) T-cell therapy has led to unprecedented results to date in relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), yet its clinical application in elderly patients with R/R DLBCL remains somewhat limited. In this study, a total of 31 R/R DLBCL patients older than 65 years of age were enrolled and received humanized anti-CD19 CAR T-cell therapy. Patients were stratified into a fit, unfit, or frail group according to the comprehensive geriatric assessment (CGA). The fit group had a higher objective response (OR) rate (ORR) and complete response (CR) rate than that of the unfit/frail group, but there was no difference in the part response (PR) rate between the groups. The unfit/frail group was more likely to experience AEs than the fit group. The peak proportion of anti-CD19 CAR T-cells in the fit group was significantly higher than that of the unfit/frail group. The CGA can be used to effectively predict the treatment response, adverse events, and long-term survival.

Keywords:

• Humanized anti-CD19 CART
• older patients
• R/R DLBCL
• comprehensive geriatric assessment
• safety evaluation

Acknowledgements

We thank the patients for their participation in our study.

Trial registration: The patients were enrolled in a clinical trial registered as ChiCTR1800018059.

Ethics approval and consent to participate: This study was approved by the Medical Ethics Committee of the Department of Hematology at Tianjin First Center Hospital (Tianjin, China) (approval no.: 2015002X and 2018N105KY). The patients provided written informed consent in accordance with the Declaration of Helsinki. The clinical trial in our study was registered at http://www.chictr.org.cn/index.aspx as ChiCTR1800018059.

Author contributions

Concept and design: DQ. Drafting or revised of the manuscript: ZH. Acquisition of data: LM, LQ, WJ, LCC, JYY, MJX, and LJY. Analysis and interpretation of data: LM and LQ. Writing, review, and/or revision of manuscript: all authors. Study supervision: DQ.

Disclosure statement

The authors have no conflicts of interest to report.