决定异体 CAR T 细胞排斥与扩增的细胞和分子机制
Cellular and molecular mechanisms determining allogeneic CAR T cell rejection and expansion.
我们评估了11例接受单一批次cemacabtagene ansegedleucel(cema-cel)治疗的大B细胞淋巴瘤患者,cemacabtagene ansegedleucel是一种异体抗CD19 CAR T产品。
英文原题:Consensus recommendations for CAR T-cell administration in adult acute lymphoblastic leukemia: a modified Delphi study.
共识专家组成员(n = 9)包括来自成人 ALL 中 CAR T 细胞治疗真实世界结局协作组(ROCCA)各中心的主要研究者(PI),其遴选基于专业能力和 CAR T 细胞中心规模。
成人 B 急性淋巴细胞白血病(B-ALL)中嵌合抗原受体(CAR)T 细胞疗法应用日益增多,目前已有 3 种 CD19 CAR-T 产品可供临床使用。该人群 CAR-T 给药最佳实践仍存在若干重要临床问题,且为填补这些知识空白所开展的前瞻性随机试验有限。因此,为指导临床实践,研究者采用改良 Delphi 法,为成人 B-ALL 商业化 CAR-T 疗法的给药制定并验证共识建议。共识专家组包括 9 名专家,来自成人 ALL CAR-T 真实世界结局协作组(ROCCA)研究中心的主要研究者(PI),根据专业经验及 CAR-T 中心治疗量选定。最终专家组建议由 ROCCA 各中心其余 PI(n=27)评分验证。共识主题包括患者选择、桥接治疗及 CAR-T 前白血病分期、淋巴细胞清除、CAR-T 治疗场景、特定毒性的预防和管理、CAR-T 后应答评估和疾病监测,以及 CAR-T 后巩固和/或维持治疗的作用。最初评估 58 项建议陈述。经过两次专家组会议,34 项获得专家共识;验证组评分后,除 1 项外其余均继续达到共识,最终形成 33 项关于成人 B-ALL CAR-T 给药的共识建议。
The use of chimeric antigen receptor (CAR) T-cell therapy is increasing for adult B-cell acute lymphoblastic leukemia (B-ALL), with 3 CD19 CAR T-cell products commercially available. Several key clinical questions related to best practices for CAR T-cell administration in this population exist, and limited prospective randomized trials have been conducted to fill these knowledge gaps. Thus, to help guide clinical practice, we conducted a modified Delphi study to develop and validate consensus recommendations on the administration of commercially available CAR T-cell therapy for adults with B-ALL. Consensus panelists (n = 9) included principal investigators (PIs) from Real World Outcomes Collaborative of CAR T-Cell Therapy in Adult ALL (ROCCA) consortium sites and were selected based on expertise and CAR T-cell center volume. Final panel consensus recommendations were distributed for rating by the remaining PIs from ROCCA consortium sites, which served as the validation group (n = 27). Consensus topics included patient selection, bridging and pre-CAR T-cell leukemia staging, lymphodepletion, and CAR T-cell treatment setting, specific toxicity prevention and management, post-CAR T-cell response assessment and disease monitoring, and the role of consolidation and/or maintenance therapies after CAR T-cell therapy. Initially, 58 recommendation statements were evaluated for consensus. After 2 panel meetings, a total of 34 statements achieved consensus rating among the expert panel. After rating by the validation group, all but 1 recommendation statement continued to meet consensus, for a total of 33 consensus recommendation statements on the administration of CAR T-cell therapy in adult B-ALL.
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