Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.)(Anti-CD19 and anti-CD20 CAR-T cell therapy(The Medical College of Wisconsin, Inc.)) - 药物靶点：CD19 x CD20_在研适应症：B细胞恶性肿瘤，滤泡性淋巴瘤，套细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

LV20.19 CAR T cells(Medical College of Wisconsin)

靶点

CD19 x CD20

作用方式

抑制剂

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、CD20抑制剂(B淋巴细胞抗原CD20抑制剂)、T淋巴细胞替代物

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [2]

在研适应症

B细胞恶性肿瘤滤泡性淋巴瘤套细胞淋巴瘤+ [7]

非在研适应症

复发性急性淋巴细胞白血病晚期边缘区淋巴瘤CD19阳性B细胞淋巴瘤+ [3]

原研机构

Medical College of Wisconsin

在研机构

Medical College of Wisconsin

非在研机构-

权益机构-

最高研发阶段临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

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

NCT07335328

/ Not yet recruiting临床1期IIT

Phase 1 Study of a Fully Human Bispecific Anti-CD20, Anti-CD19 CAR T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies

This is a Phase 1 interventional, single-arm, open- label, treatment study designed to evaluate the safety of h20.19 CAR T cells in patients with B-cell malignancies that have failed prior therapies.

开始日期2026-09-01

申办/合作机构

Medical College of Wisconsin

NCT05990465

/ Recruiting临床1期IIT

Phase I Study of LV20.19 CAR T-cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies

This is a phase I, interventional, single arm, open label, treatment study designed to evaluate the safety and efficacy of LV20.19 CAR -T cells with pirtobrutinib bridging and maintenance in adult patients with B cell malignancies that have failed prior therapies.

开始日期2025-02-06

申办/合作机构

Medical College of Wisconsin

NCT04049383

/ Terminated临床1期IIT

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

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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3

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

2025-07-10·JOURNAL OF CLINICAL ONCOLOGY

Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma

Article

作者: Cunningham, Ashley ; Vargas-Cortes, Marlenny ; Palen, Katie ; Dwinell, Michael B. ; Longo, Walter ; Kearl, Tyce ; Hamadani, Mehdi ; Zamora, Anthony E. ; Bucklan, Daniel ; Johnson, Bryon D. ; Szabo, Aniko ; Shah, Nirav N. ; Schneider, Dina ; Furqan, Fateeha ; Hematti, Peiman ; Hari, Parameswaran ; Fenske, Timothy S. ; Schmeling, Jessica L. ; Colina, Alfredo S.

PURPOSE:

Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy characterized by t(11;14) and bright CD20 expression. To improve outcomes from single targeted CD19 chimeric antigen receptor (CAR) T cells, we used dual targeted lentiviral anti-CD20/anti-CD19 (LV20.19) CAR T cells as part of a phase I/II clinical trial in relapsed, refractory (R/R) MCL (ClinicalTrials.gov identifier: NCT04186520 ).

METHODS:

Patients with MCL who had failed two lines of therapy or relapsed post-transplant were eligible. LV20.19 CAR T cells were manufactured on-site via CliniMACS Prodigy using an adaptive 8- to 12-day process to optimize the final CAR product for increased numbers of naïve and stem-cell memory (SCM) like T cells.

RESULTS:

Seventeen patients with R/R MCL received a single dose of LV20.19 CAR T cells at 2.5 × 10 6 cells/kg (phase I = three patients; phase II = 14 patients). The best overall response rate (ORR) was 100% (complete response [CR] = 88%; partial response = 12%) and the phase II efficacy threshold for day-90 CR rate was exceeded. Two patients have relapsed as of the data cutoff and neither the median progression-free survival nor overall survival has been reached with a median follow-up of 15.8 months. Ninety-four percent (n = 16) experienced cytokine release syndrome, all grade 1-2. Eighteen percent (n = 3) had immune effector cell–associated neurotoxicity syndrome in the first 28-days, two with reversible grade 3 toxicity. Three patients had nonrelapse mortality events; all occurred in the setting of ongoing B-cell aplasia. The final LV20.19 CAR products were enriched for higher percentages of T- SCM /T-naïve cells and most patients received CAR T cells within 8 days of apheresis.

CONCLUSION:

In conclusion, we demonstrate that on-site adaptive manufactured LV20.19 CAR T cells are feasible, safe, and efficacious for R/R MCL with best ORR of 100%, a favorable safety profile, and few relapses to date.

2022-08-01·CYTOTHERAPY3区 · 医学

Bispecific targeting of CD20 and CD19 increases polyfunctionality of chimeric antigen receptor T-cell products in B-cell malignancies

3区 · 医学

Article

作者: Parameswaran Hari ; Dina Schneider ; Aniko Szabo ; Nirav N. Shah ; Katherine Chaney ; Bryon D. Johnson ; Huiqing Xu ; Joanna C. Zurko

BACKGROUND AIMS:

Selective immune pressure contributes to relapse due to target antigen downregulation in patients treated with anti-CD19 chimeric antigen receptor (CAR) T cells. Bispecific lentiviral anti-CD20/anti-CD19 (LV20.19) CAR T cells may prevent progression/relapse due to antigen escape. Highly polyfunctional T cells within a CAR T-cell product have been associated with response in single-antigen-targeted anti-CD19 CAR T cells.

METHODS:

The authors performed a single-cell proteomic analysis to assess polyfunctional cells in our LV20.19 CAR T-cell product. Analysis was limited to those treated at a fixed dose of 2.5 × 10⁶ cells/kg (n = 16). Unused pre-infusion CAR T cells were thawed, sorted into CD4/CD8 subsets and stimulated with K562 cells transduced to express CD19 or CD20. Single-cell production of 32 individual analytes was measured and polyfunctionality and polyfunctional strength index (PSI) were calculated.

RESULTS:

Fifteen patients had adequate leftover cells for analysis upon stimulation with CD19, and nine patients had adequate leftover cells for analysis upon stimulation with CD20. For LV20.19 CAR T cells, PSI was 866-1109 and polyfunctionality was 40-45%, which were higher than previously reported values for other CAR T-cell products.

CONCLUSIONS:

Stimulation with either CD19 or CD20 antigens resulted in similar levels of analyte activation, suggesting that this product may have efficacy in CD19- patient populations.

Haematologica

Associations between socioeconomic status and bispecific LV20.19 CAR T-cell therapy outcomes

Letter

作者: Ruizhe Wu ; Jennifer M. Knight ; Garrett Sauber ; Rachel N. Cusatis ; Cecilia J. Hillard ; Aniko Szabo ; Elizabeth Aughey ; Steve W. Cole ; Nirav N. Shah ; Edward Hackett ; Bryon Johnson

Chimeric antigen receptor (CAR) T-cell therapy utilization has risen sharply in recent years, becoming a standard approach for refractory B-cell malignancies.The current study population (n=15) is derived from the previously reported parent study (n=22) evaluating patients with relapsed, refractory B-cell malignancies treated with LV20.19 CAR T cells on a phase I/Ib clin. trial ( clinicaltrials gov. Identi fi er: NC T03019055 ).All participants provided written informed consent and all procedures were approved in advance by the MCW Institutional Review Board.Patient income was self-reported based on household annual income as either above (high SES) or below (low SES) the 2021 Wisconsin median of$54,660. Further details are described elsewhere.This study is limited by the small sample size.These provocative findings need to be further evaluated in a largercohort wherein addnl. patient-, disease-, and CAR T- related variables can be appropriately controlled for and mediational analyses conducted.

1

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

2025-07-11

·今日头条

《自然医学》重磅：双特异性CAR-T暴击复发性肿瘤，总缓解率达82%

全球顶级医学期刊《自然医学》报道了一项“应用双特异性抗CD20/抗CD19的LV20.19嵌合抗原受体（CAR）T细胞，治疗复发性B细胞非霍奇金淋巴瘤或慢性淋巴细胞白血病”的Ⅰ期临床研究（NCT03019055）结果令人振奋：此款CAR-T在复发性B细胞非霍奇金淋巴瘤或慢性淋巴细胞白血病成年患者中，能产生较高的反应率。这项研究针对的是病情反复的患者，而“双特异性”设计让CAR-T细胞像装了双重“瞄准镜”，能更精准地锁定癌细胞。对那些在治疗中屡屡受挫的病友来说，这样的突破不仅带来了当下的疗效希望，更预示着免疫治疗正在向更精准、更有效的方向迈进，为血液肿瘤的治疗注入了更强助力！ ▲截图源自“Nature medicine” 双特异性CAR-T疗法创佳绩：82%患者缓解，非冻存输注让完全缓解率飙至92% 该研究共纳入26名符合条件的患者，最终22例患者接受了LV20.19CAR-T细胞输注（目标剂量包括：3例接受2.5×10⁵个细胞/kg、3例接受7.5×10⁵个细胞/kg、16例接受2.5×10⁶个细胞/kg），其中15例（68%）患者采用非冻存输注方式。结果显示：所有患者中位总生存期（OS）为20.3个月（详见下图）。第28天达到缓解的患者中，外周血CAR-T细胞数量在第7-12天达峰值，第90天时降至较低水平或无法检测。值得注意的是，复发或治疗失败患者中未出现CD19抗原丢失。在22例可评估疗效的患者中，第28天总体缓解率达82% （18例），其中完全缓解（CR）率为64%（14例）；4例达到部分缓解（PR）。 ▲图源“Nature medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除 1、按病种细分：11例弥漫大B细胞淋巴瘤患者中 10例缓解，7例套细胞淋巴瘤患者中 4例缓解， 3例慢性淋巴细胞白血病患者全部缓解，1例滤泡性淋巴瘤患者缓解。 2、不同输注方式与剂量的疗效更值得关注：非冻存输注患者的第28天反应率（93%），高于解冻后输注者（57%，P=0.08）。此外，接受2.5×10⁶个细胞/kg剂量的16例患者中， 88%（14例）缓解，75%（12例）完全缓解；而该剂量下采用非冻存输注的12例患者，缓解率达100% （其中92%为完全缓解）。下图展示了3例代表性患者（患者01、患者11、患者26）在CAR-T治疗前后的PET/CT对比图。 ▲图源“Nature medicine”，版权归原作者所有，如无意中侵犯了知识产权，请联系我们删除综上，现场制备并输注非冻存LV20.19CAR-T细胞可行且安全，具有低毒性、高疗效的特点；双特异性CAR-T可通过减轻靶抗原下调（一种复发机制）进一步提升临床疗效。小编寄语 CAR-T细胞疗法作为免疫细胞疗法中的“佼佼者”，其在血液肿瘤中的治疗效果有目共睹，中美等国更是有多款产品相继获批上市。值得欣慰的是，近年来研究人员开始将研发重点集中在CAR-T治疗实体瘤方面，并取得了不俗的成绩。近年来，CAR-T研发更是进入了“百家争鸣”的局面，仅2024上半年就有四款CAR-T产品在中美等国获批上市，助癌症患者从黑暗走向光明！参考资料 [1]Shah N N,et al.Bispecific anti-CD20, anti-CD19 CAR T cells for relapsed B cell malignancies: a phase 1 dose escalation and expansion trial[J]. Nature medicine, 2020, 26(10): 1569-1575. https://www.nature.com/articles/s41591-020-1081-3 本文为全球肿瘤医生网原创，未经授权严禁转载

细胞疗法免疫疗法临床1期临床结果基因疗法

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

10 条进展最快的记录,

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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
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
里氏综合症	临床2期	美国	Medical College of Wisconsin	2020-05-18
伯基特淋巴瘤	临床1期	美国	Medical College of Wisconsin	2025-02-06
复发性急性淋巴细胞白血病	临床1期	美国	Medical College of Wisconsin	2020-10-16
难治性 T 急性淋巴细胞白血病	临床1期	美国	Medical College of Wisconsin	2020-10-16

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临床结果

适应症

分期

评价

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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 (ASH2025)	临床1/2期	原发性中枢神经系统淋巴瘤	6	LV20.19 CAR T cells	壓廠廠衊築醖鬱齋製淵(襯衊築鹽襯餘獵選壓膚) = 願壓憲餘窪簾窪衊鏇遞鬱網選構鏇淵選積鑰憲 (觸獵壓襯襯艱襯廠鏇繭 ) 更多	积极	2025-12-06
NCT04186520 (ASH2025)	临床1/2期	弥漫性大B细胞淋巴瘤	42	LV20.19 CAR T-cells (8-day fresh)	鹽糧艱願鹹願膚膚觸範(醖製鑰襯繭鏇鹹淵鬱構) = 鬱構蓋獵廠餘鹽廠壓簾遞襯糧衊壓顧廠衊獵齋 (範選鏇窪鑰網簾製獵鏇 ) 更多	积极	2025-12-06
				LV20.19 CAR T-cells (12-day fresh)	鹽糧艱願鹹願膚膚觸範(醖製鑰襯繭鏇鹹淵鬱構) = 獵膚願衊醖顧觸製獵鹹遞襯糧衊壓顧廠衊獵齋 (範選鏇窪鑰網簾製獵鏇 ) 更多
NCT03019055 (NEWS) 人工标引	临床1期	慢性淋巴细胞白血病 \| 复发性非霍奇金淋巴瘤	26	LV20.19CAR-T	齋襯齋願鹽顧淵願醖範(鑰鬱憲壓憲窪糧鏇鏇廠) = 糧鏇築衊窪選獵窪遞糧鑰構艱壓網鹽淵壓顧壓 (願選鹽窪獵窪鹹醖壓膚 )	积极	2025-07-11
				LV20.19CAR-T (弥漫大B细胞淋巴瘤)	選獵構鑰簾遞製醖觸蓋(壓積顧窪網簾醖範膚襯) = 鑰齋製艱廠簾衊繭願衊壓獵廠鑰顧壓壓蓋糧憲 (選鹽憲糧壓窪壓繭獵簾 )
NCT04186520 (Tandem Meetings ASTCT and CIBMTR2025)	临床1/2期	弥漫性大B细胞淋巴瘤	5	LV20.19 CAR T cells	獵糧窪鑰蓋鏇蓋鹽鹽願(觸廠蓋襯蓋築蓋艱蓋顧) = 夢襯夢製鹽積鹽積鬱繭顧鏇製鬱衊鹽鑰醖憲夢 (憲壓衊繭網廠醖窪構壓 )	积极	2025-02-12
				LV20.19 CAR T cells (ctDNA MRD)	獵糧窪鑰蓋鏇蓋鹽鹽願(觸廠蓋襯蓋築蓋艱蓋顧) = 壓構壓膚網廠顧簾糧遞顧鏇製鬱衊鹽鑰醖憲夢 (憲壓衊繭網廠醖窪構壓 )
NCT04186520 (ASH 12022 \| ASH 22022) 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)	壓範壓鹽遞選廠鹹遞蓋(齋範憲窪遞襯膚憲糧觸) = 糧獵顧餘觸網鏇壓願繭簾廠窪淵簾膚顧遞繭構 (願艱簾艱齋蓋觸齋遞鏇 ) 更多	积极	2022-11-15
				CAR-20/19-T cells (12-day fixed MF arm)	壓範壓鹽遞選廠鹹遞蓋(齋範憲窪遞襯膚憲糧觸) = 築壓餘簾願夢願壓顧顧簾廠窪淵簾膚顧遞繭構 (願艱簾艱齋蓋觸齋遞鏇 ) 更多
NCT04186520 (ASH 12021 \| ASH 22021) 人工标引	临床1/2期	难治性B细胞淋巴瘤三线	22	LV20.19 CAR T-cells 2.5x10^6 cells/kg	齋餘顧觸簾壓簾壓憲艱(築範膚觸餘獵製簾遞鏇) = 築鏇醖選蓋艱鹹願膚蓋鏇製窪壓積製觸鹹網衊 (鬱蓋糧鹹網淵艱艱獵獵 ) 更多	积极	2021-11-05
				LV20.19 CAR T-cells 2.5x10^6 cells/kg (8-day arm (Phase 1 & 1B cohorts))	積餘齋醖衊網膚鏇憲蓋(憲製製窪選簾蓋膚觸繭) = 鬱鹹鹽構襯選簾範獵簾繭夢觸餘積製淵鑰觸鏇 (衊廠憲夢構鏇觸齋鏇窪 )
NCT03019055 (O158, CTgov)	临床1期	慢性淋巴细胞白血病 \| 晚期边缘区淋巴瘤 \| B细胞淋巴瘤 ... 更多	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))	範膚蓋繭築夢願憲繭鹽(積獵醖範願糧顧網壓醖) = 鏇鹹製鬱衊艱簾鹽艱淵壓築獵觸鹹齋餘憲窪顧 (製鏇膚願簾蓋膚構憲遞, 繭觸製積鬱衊窪製衊遞 ~ 淵餘鏇築網獵鹹餘夢齋) 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))	廠艱齋積鹹積衊淵範鹽 = 選壓繭構壓鬱壓繭窪遞鬱顧鹹遞築襯繭鬱遞繭 (憲鏇齋餘齋鹹膚衊窪齋, 獵餘窪願憲網鑰夢窪憲 ~ 簾獵窪積鏇齋構蓋築遞) 更多
Tandem Meetings ASTCT and CIBMTR2021	N/A	Carney复合症	-	IL-2-expanded LV20.19 CAR T-cells	廠夢衊網網窪簾壓顧範(選餘壓餘憲壓壓製鏇壓) = rates of cytokine release syndrome (CRS) and neurotoxicity were comparable 範構壓願鏇範觸製選衊 (鏇餘製醖鏇夢鹽糧壓蓋 )	-	2021-03-01
				IL-7+15 expanded LV20.19 CAR T-cells
NCT04186520 (Phase I/II trial of LV20.19 CAR T-cells expanded with IL-7+15 in R/R NHL, Tandem Meetings ASTCT and CIBMTR2021)	临床1/2期	Carney复合症	-	LV20.19 CAR T-cells expanded with IL-2	糧壓襯糧鏇窪遞鑰構衊(壓壓選積蓋夢窪獵窪製) = CRS occurred in 83% (n=5, grade 1) in the IL-7+15 cohort and 73% (n=8, grade 1-4) in the IL-2 cohort 淵襯願顧製廠蓋製艱選 (壓繭壓網選繭衊範遞鑰 )	积极	2021-03-01
				LV20.19 CAR T-cells expanded with IL-7+15
NCT03019055 (Pubmed) 人工标引	临床1期	慢性淋巴细胞白血病 \| 非霍奇金淋巴瘤	22	LV20.19 CAR T (2.5×10⁶ cells/kg)	壓憲構艱餘憲鬱願繭餘(餘憲醖夢鬱淵膚製夢夢) = 餘夢簾積積觸願艱選鏇壓遞糧選窪築鹹齋鹽獵 (觸窪製鹹鬱鹽鑰衊顧艱 ) 更多	积极	2020-10-01
				LV20.19 CAR T (2.5×10⁶ cells per kg with non-cryopreserved infusion)	壓憲構艱餘憲鬱願繭餘(餘憲醖夢鬱淵膚製夢夢) = 範壓鹹鏇製鹽獵繭蓋鹹壓遞糧選窪築鹹齋鹽獵 (觸窪製鹹鬱鹽鑰衊顧艱 ) 更多