Phase 1 Study of Redirected Autologous T Cells Engineered to Contain an Anti-CD19 and Anti-CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed/ Refractory CD19 or CD20 B-cell Acute Lymphoblastic Leukemia

This phase 1 study will evaluate the safety and efficacy of a CAR-T cell therapy directed against two B cell antigens (CD19 CD20) and produced under good manufacturing practice (GMP) conditions using the closed system CliniMACS Prodigy device in B ALL.

开始日期2020-10-16

申办/合作机构

Medical College of Wisconsin

NCT04186520 / Recruiting临床1/2期IIT

Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

This is a Phase I/II, interventional, single-arm, open-label, treatment study designed to evaluate the safety and efficacy of Interleukin-7 and Interleukin-15 (IL-7/IL-15) manufactured chimeric antigen receptor (CAR)-20/19-T cells as well as the feasibility of a flexible manufacturing schema in adult patients with B cell malignancies that have failed prior therapies.

开始日期2020-05-18

申办/合作机构

Medical College of Wisconsin

NCT03019055 / Completed临床1期IIT

Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies

This is a phase 1/1b, interventional single arm, open label, treatment study designed to evaluate the safety and feasibility of infusion of autologous T cells engineered to contain an anti-cluster of differentiation 19 (CD19) and anti-cluster of differentiation 20 (CD20) single chain variable fragment (scFv) coupled to cluster of differentiation CD3ζ (CD3ζ) and co-stimulatory domain 4-1BB (4-1BB) signaling domains in patients with relapsed and/or refractory CD19 or CD20 positive B cell malignancies

开始日期2017-10-16

申办/合作机构

Medical College of Wisconsin

100 项与 Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.) 相关的临床结果

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100 项与 Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.) 相关的转化医学

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100 项与 Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.) 相关的专利（医药）

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项与 Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.) 相关的文献（医药）

2020-08-01·Cancer Medicine3区 · 医学

Phase II trial of co‐administration of CD19‐ and CD20‐targeted chimeric antigen receptor T cells for relapsed and refractory diffuse large B cell lymphoma

3区 · 医学

ArticleOA

作者: Zhang, Bing ; Li, Weidong ; Liu, Hui ; Yan, Dongmei ; Yao, Meixue ; Wu, Mei ; Xu, Kailin ; Zheng, Junnian ; Ma, Yuanyuan ; Sun, Haiying ; Li, Depeng ; Shi, Ming ; Cao, Jiang ; Li, Zhenyu ; Yang, Jingjing ; Yan, Zhiling ; Sun, Cai ; Zhu, Feng ; Wang, Ying ; Song, Xuguang ; Zeng, Lingyu ; Sang, Tingting ; Gao, Xiang ; Sun, Kemeng ; Sang, Wei ; Xu, Linyan ; Qin, Yuanyuan ; Jiao, Jun ; Cheng, Hai

AbstractPurposeAnti‐CD19 chimeric antigen receptor T (CAR‐T) cell therapy has demonstrated remarkable efficacy for refractory and relapsed diffuse large B cell lymphoma (R/R DLBCL). However, this therapy failed in nearly 25% patients mainly due to antigen loss. The authors performed a phase Ⅱ trial by coadministration of anti‐CD19 and anti‐CD20 CAR‐T cells treatment for R/R DLBCL and evaluated its efficacy and toxicity.MethodsTotally 21 patients with DLBCL were enrolled in this study. The patients were conditioned with fludarabine and cyclophosphamide before the infusion of anti‐CD19 and anti‐CD20 CAR‐T cells. Treatment response, toxicity, and persistence were monitored continuously.ResultsOf the 21 patients received the treatment, the objective response rate (ORR) is 81.0% (95% confidence interval [CI], 58.1%‐94.6%) with four cases of bulk (4/5) and one case of testis involvement; 52.4% (95% CI, 29.8%‐74.3%) had a complete response (CR). Peak levels of anti‐CD19 and anti‐CD20 CAR cells were associated with response (P = .007 and .002). Grade 3‐4 cytokine release syndrome (CRS) and neurologic events occurred in 28.5% and 9.5% patients, respectively. Median overall survival (OS) and progression‐free survival (PFS) were 8.1 and 5.0 months, respectively. The maximum standard uptake value (SUVmax) of CD4/CD8 ratio before and after infusion were associated with responses, and the total lesion glycolysis (TLG) before infusion correlates with cytokines level.ConclusionsCoadministration of anti‐CD19 and CD20 CAR‐T cells therapy for DLBCL is feasible with manageable toxicity. Cytokine markers are related to toxicity and SUVmax could predict efficacy. This trial was registered at www.clinicaltrials.gov as NCT03207178.

100 项与 Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
B细胞恶性肿瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18
慢性淋巴细胞白血病	临床2期	美国	Medical College of Wisconsin	2020-05-18
滤泡性淋巴瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18
套细胞淋巴瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18
边缘区B细胞淋巴瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18
纵隔大b细胞淋巴瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18
原发性中枢神经系统淋巴瘤	临床2期	美国	Medical College of Wisconsin	2020-05-18

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临床结果

适应症

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04186520 (ASH2022) 人工标引	临床1/2期	B细胞淋巴瘤	21	CAR-20/19-T cells (flexible 8/12 MF arm)	(齋糧壓顧願鬱願壓憲齋) = 憲簾觸餘憲淵顧網夢網簾積製艱簾糧餘鹽顧鹹 (製壓選醖顧壓選遞獵遞 ) 更多	积极	2022-11-15
				CAR-20/19-T cells (12-day fixed MF arm)	(齋糧壓顧願鬱願壓憲齋) = 衊壓築壓鹹糧醖簾齋壓簾積製艱簾糧餘鹽顧鹹 (製壓選醖顧壓選遞獵遞 ) 更多
NCT03019055 (O158, CTgov)	临床1期	慢性淋巴细胞白血病 \| B细胞淋巴瘤 \| 小淋巴细胞淋巴瘤 \| B细胞恶性肿瘤	26	CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg) (CAR-20/19-T Cells (1.0 x10^5 CAR-20/19-T Cells/kg))	鏇壓膚遞獵構繭製積餘(醖顧淵遞醖淵憲選範襯) = 鑰範餘糧願積膚製糧鹽簾餘獵願鏇鏇遞膚範糧 (積膚構鑰鏇餘願選齋遞, 製淵糧願鹹顧製選簾網 ~ 蓋獵襯簾壓窪網窪糧遞) 更多	-	2021-05-07
				CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg) (CAR-20/19-T Cells (2.5 x10^5 CAR-20/19-T Cells/kg))	襯鹽淵壓顧獵網鏇觸製(鬱壓廠壓淵積構選積製) = 範糧願觸鬱鏇糧鬱簾鏇夢鬱積艱網齋糧遞鬱壓 (構鑰構鹽獵選鬱遞淵醖, 鬱築艱壓夢鑰衊鑰窪廠 ~ 壓齋鏇膚憲範構餘網憲) 更多