CAR-T cells have become a major source of cellular immunotherapy in China. This study summarized the CAR-T clinical trials being conducted in China and provided a quick glimpse of the landscape of CAR-T studies in China. Methods We searched ClinicalTrials.gov using keywords “CAR T,”“CAR-...
2.Comparabilitystudydesign18 E.Single-SiteorMultisiteCARTCellManufacturing19 1.Single-sitemanufacturing19 2.Multisitemanufacturing19 3.Multisitetesting20 V.NONCLINICALRECOMENDATIONS20 A.NonclinicalConsiderationsfortheCARConstruct20 B.NonclinicalConsiderationsfortheCellularComponentofCARTCells22 ...
上一期,我们介绍了“基于ClinicalTrials.gov数据库分析的CAR-T细胞治疗临床试验概览”,不难看出,全球正在开展的CAR-免疫细胞临床试验的国家众多,在肿瘤细胞免疫治疗领域,中国大陆以“465个临床试验”位居首位,美国紧随其后(图1)。 事实上,与美国CAR-T细胞疗法商业化已经形成相对成熟的模式不同,在中国,至今未有批准上...
Clinical trial information and design This study was a phase 1, open-label, single-arm clinical trial designed to evaluate the safety and efficacy of non-viral,PD1-integrated anti-CD19 CAR-T cells in treating aggressive r/r B-NHL. The clinical protocol has been registered at ClinicalTrials...
b, Outline of clinical trial design. D0, day 0; LD, lymphodepleting chemotherapy. c, Post-mortem examination of participant 1 with DIPG (DIPG-1). From left to right: haemotoxylin and eosin staining; CD3 immunohistochemistry (brown); GD2-CAR mRNA puncta (pink; haematoxylin counterstain for...
16. Kochenderfer JN, Dudley ME, Feldman SA, et al. B-cell depletion and remissions of malignancy along with cytokine-associated toxicity in a clinical trial of anti-CD19 chimeric-antigen-receptor-transduced T cells [J]. Blood, 2012, 119(12): p. 2709-20. doi: 10.1182/blood-2011-10-...
is sponsor of a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 CD20 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ and CD20+haematological malignancies (...
近日，美国MD安德森癌症中心领衔多家癌症研究机构同Kite制药合作，在Nature Medicine发表题为Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial的临床试验研究。在这项多中心、单臂临床试验中(ZUMA-12, Clinical Trials.gov NCT03761056)，研究者初期...
A recent clinical study introduced a new approach for the generation of gene-targeted CAR-T cells through the application of CRISPR-Cas9 technology [65]. By implementing a non-viral two-in-one strategy, researchers successfully incorporated PD-1 into the cells to enhance the immune function. The...
(GC) in a preclinical study. Here we report the interim analysis results of an ongoing, open-label, single-arm, phase 1 clinical trial of CLDN18.2-targeted CAR T cells (CT041) in patients with previously treated, CLDN18.2-positive digestive system cancers (NCT03874897). The primary ...