更新于：2023-10-01

BYC-104

更新于：2023-10-01

概要

研发状态

概要

基本信息

药物类型

CAR-T

别名

Anti-CD19 CAR-T cell therapy(Bioray Laboraytories Inc)、CART-19 cells(Bioray Laboraytories)、Targeting hcd19 chimeric antigen receptor(Bioray Laboraytories)

+ [7]

靶点

CD19 + EBV蛋白(B淋巴细胞抗原CD19 + EBV蛋白)

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、EBV蛋白抑制剂、基因转移

+ [1]

治疗领域

肿瘤、免疫系统疾病、血液及淋巴系统疾病

在研适应症

白血病、B细胞淋巴瘤

非在研适应症-

原研机构

上海邦耀生物科技有限公司

在研机构

上海邦耀生物科技有限公司

非在研机构-

最高研发状态(全球)临床2期

首次获批日期(全球)-

最高研发状态(中国)临床2期

特殊审评-

关联

项与 BYC-104 相关的临床试验

NCT05326243 / Recruiting临床1/2期

A Phase 1/2 Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of CD19-targeted Chimeric Antigen Receptor T-cell (CD19 CAR-T) Therapy in Patients With Relapsed or Refractory B-cell Lymphoma

This is a multiple center, non-randomized, open-label, phase 1/2 study. The primary objective of Phase 1 is to evaluate the safety of PL001 and find the recommended Phase 2 dose (RP2D). The objective of Phase 2 is to evaluate the safety and efficacy of CD19 CAR-T(known as PL001).

开始日期2022-05-31

申办/合作机构

PELL Bio-Med Technology Co., Ltd.

NCT04943016 / Not yet recruiting临床1期IIT

Phase I Clinical Trial of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies

This study seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children and adults with relapsed/refractory B cell malignancies.

开始日期2021-07-01

申办/合作机构

National Taiwan University Hospital

ChiCTR2000040018 / Suspended临床1期

Phase the Safety and Tolerability of CD19 Universal Chimeric Antigen Receptor T Cells in Subjects with R/R CD19 positive B cell malignant tumors

开始日期2021-01-01

申办/合作机构

南通大学附属医院

100 项与 BYC-104 相关的专利（医药）

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项与 BYC-104 相关的文献（医药）

2023-08-23·Arthritis & rheumatology (Hoboken, N.J.)

Effects of B cell depletion by CD19-targeted CAR-T cells in a murine model of systemic sclerosis.

Article

作者: Jérôme Avouac ; Anne Cauvet ; Cindy Orvain ; Morgane Boulch ; Françoise Tilotta ; Ly Tu ; Raphaël Thuillet ; Mina Ottaviani ; Christophe Guignabert ; Philippe Bousso ; Yannick Allanore

OBJECTIVE:

To study the tolerance and efficacy of two B cell depletion strategies, including one with CD19-targeted chimeric antigen receptor (CAR) T cells, in a preclinical model mimicking the severe lung damages observed in systemic sclerosis (SSc).

METHODS:

B cell depletion strategies were evaluated in the Fra-2 transgenic (Tg) mouse model. We considered a first group of 16 untreated mice, a second group of 15 mice receiving a single dose of anti-CD20 monoclonal antibody (mAb) and a third group of 8 mice receiving CD19-targeted CAR-T cells in combination with anti-CD20 monoclonal antibody. After 6 weeks of clinical evaluation, different validated markers of inflammation, lung fibrosis and pulmonary vascular remodeling were assessed.

RESULTS:

CD19-targeted CAR-T cells infusion in combination with anti-CD20 mAb resulted in a deeper B cell depletion than anti-CD20 mAb alone in the peripheral blood and lesional lungs of Fra-2 Tg mice. CAR-T cell infusion worsened clinical score and increased mortality in Fra-2 Tg mice. In line with the above findings, CAR-T cell infusion significantly increased lung collagen content, histological fibrosis score and right ventricular systolic pressure. CAR-T cells accumulated in lesional lungs and promoted T activation and inflammatory cytokine production. Treatment with anti-CD20 mAb in monotherapy had no impact on lung inflammation-driven fibrosis and pulmonary hypertension.

CONCLUSION:

B-cell therapies failed to show efficacy in the Fra2 transgenic mice. The exacerbated Fra-2 lung inflammatory burden stimulated accumulation and expansion of activated CD19-targeted CAR-T cells, secondarily inducing T-cell activation and systemic inflammation, finally leading to disease worsening.

2023-08-11·Leukemia & lymphoma

Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma.

Article

作者: Shalev Fried ; Eden Shkury ; Orit Itzhaki ; Inbal Sdayoor ; Ronit Yerushalmi ; Noga Shem-Tov ; Ivetta Danylesko ; Elad Jacoby ; Roni Shouval ; Meirav Kedmi ; Ronit Marcus ; Arnon Nagler ; Avichai Shimoni ; Abraham Avigdor

Patients with relapsed/refractory follicular lymphoma (R/R-FL) often require multiple treatment lines. We performed a phase 1b/2 single-center clinical trial of autologous point-of-care anti-CD19 chimeric antigen receptor (CAR) T-cells in R/R-FL patients treated patients with ≥ 2 treatment lines. All 26 patients enrolled received CAR T-cell infusion at a median of 11 days after leukapheresis. Seventy-seven percent of patients had POD24. At enrollment, disease stage was III-IV in 85% of the patients, 77% had high-risk FLIPI score, and 77% had progressive disease. Grade III-IV cytokine release and immune effector cell-associated neurotoxicity syndromes occurred in 12% and 16% of the patients, respectively. Overall response rate at 1-month was 88%. The median follow-up was 15.4 months. One-year overall and progression-free survival were 100% and 63%, respectively. In conclusion, point-of-care CAR T-cell, manufactured within 11 days, induced a high response rate with an acceptable safety profile in patients with high-risk R/R-FL.

2023-07-25·European journal of haematology

Hematopoiesis and immune reconstitution after CD19 directed chimeric antigen receptor T-cells (CAR-T): A comprehensive review on incidence, risk factors and current management.

Review

作者: Eugenio Galli ; Alberto Fresa ; Silvia Bellesi ; Elisabetta Metafuni ; Elena Maiolo ; Ilaria Pansini ; Filippo Frioni ; Francesco Autore ; Maria Assunta Limongiello ; Idanna Innocenti ; Sabrina Giammarco ; Patrizia Chiusolo ; Gina Zini ; Federica Sorà

Impaired function of hematopoiesis after treatment with chimeric antigen T-cells (CAR-T) is a frequent finding and can interest a wide range of patients, regardless of age and underlying disease. Trilinear cytopenias, as well as hypogammaglobulinemia, B-cell aplasia, and T-cell impairment, can severely affect the infectious risk of CAR-T recipients, as well as their quality of life. In this review, we provide an overview of defects in hematopoiesis after CAR-T, starting with a summary of different definitions and thresholds. We then move to summarize the main pathogenetic mechanisms of cytopenias, and we offer insight into cytomorphological aspects, the role of clonal hematopoiesis, and the risk of secondary myeloid malignancies. Subsequently, we expose the major findings and reports on T-cell and B-cell quantitative and functional impairment after CAR-T. Finally, we provide an overview of current recommendations and leading experiences regarding the management of cytopenias and defective B- and T-cell function.

项与 BYC-104 相关的新闻（医药）

2022-11-07

·PRNewswire

CAR T-cell Therapy Pipeline Analysis Demonstrates 450+ Novel Therapies at the Horizon Expected to Transform the Treatment Paradigm | DelveInsight

CAR T-cell therapy clinical trial pipeline constitutes 193+ key companies continuously working towards developing 450+ CAR T-cell therapies, analyzes DelveInsight LAS VEGAS, Nov. 7, 2022 /PRNewswire/ -- DelveInsight's ' CAR T-cell Therapy Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline CAR T-cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the CAR T-cell therapy competitive domain. Key Takeaways from the CAR T-cell Therapy Pipeline Report Over 193+ CAR T companies are evaluating 450+ CAR T-cell therapies in various stages of development, and their anticipated acceptance in the CAR T-cell therapy market would significantly increase market revenue. Leading CAR T companies such as Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others are evaluating novel CAR T-cell Therapy drugs candidate to improve the treatment landscape. Key CAR T pipeline therapies in various stages of development include Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. In May 2022, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for treating patients with primary central nervous system lymphoma. In March 2022, JW Therapeutics announced that it had received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. In June 2021, based on ZUMA-3 study data, the US FDA accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. In April 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and refractory multiple myeloma. In March 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for treating multiple myeloma. Request a sample and discover the recent advances in CAR T therapies @ CAR T-cell Therapy Competitive Landscape Report CAR T-cell Therapy Overview Chimeric antigen receptors (CARs) are recombinant antigen receptors that redirect the specificity and function of T lymphocytes and other immune cells in a single molecule. Cancer Immunotherapy is one of the most promising approaches for treating severe diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) because it uses and improves the immune system's standard capacity. CAR T-cells are proteins that are fusions of a specific monoclonal antibody's single-chain fragment variable and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains—most commonly, a single-chain variable fragment (scFv) derived from antibody variable domains—with TCR chain signaling domains and costimulatory domains from receptors such as CD28, OX40, and CD137. For more information about CAR T-cell therapy drugs; visit @ CAR T-cell Therapy Process CAR T-cell Therapy Pipeline Analysis: Drug Profile JWCAR029: JW Therapeutics JW Therapeutics drug JWCAR029 is a CAR-T cell product that targets CD19 and is intended to treat advanced lymphoma and leukemia (Second-line therapy or greater). The molecule is currently in phase II of development. JWCAR029 is initially being investigated for the treatment of B-cell malignancies, with a focus on relapsed and refractory DLBCL. The National Medical Products Administration ("NMPA") accepted for review its NDA for relma-cel as a third-line treatment for DLBCL in June 2020. KTE-X19: Gilead Sciences Gilead Sciences drug KTE-X19 is an autologous CD19 CAR T-cell therapy under investigation. The drug is manufactured using the XLP process, including T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is required in certain B-cell malignancies for which KTE-X19 is being studied. KTE-X19 is currently in Phase II clinical trials for the treatment of both adult and pediatric acute lymphocytic leukemia. Brexucabtagene autoleucel (formerly KTE-X19; Tecartus) has been approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). A snapshot of the CAR T-cell Therapy Pipeline Drugs mentioned in the report: Learn more about FDA approved CAR T-cell therapy @ CAR T Clinical Trials Scope of the CAR T-cell Therapy Competitive Landscape Report Coverage: Global Key CAR T-cell Therapy Companies: Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others Key CAR T-cell Therapies in Pipeline: Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. Dive deep into rich insights for CAR T-cell therapy drugs; visit @ FDA-approved CAR T-cell Therapy Table of Contents For further information on the CAR T-cell therapy pipeline therapeutics, reach out @ CAR T-cell Therapy Clinical Trials Related Reports CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Market CAR T-cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Pipeline CAR T-cell Therapy for Multiple Myeloma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. 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Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

基因疗法抗体孤儿药生物类似药细胞疗法

研发状态

适应症	最高研发状态	国家/地区	公司
白血病	临床2期	中国更多	上海邦耀生物科技有限公司更多
B细胞淋巴瘤	临床阶段不明	中国更多	上海邦耀生物科技有限公司更多

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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


NCT01593696 (CTgov)	临床1期	B细胞慢性淋巴细胞白血病 \| 急性淋巴细胞白血病 \| B细胞淋巴瘤 CD19 Overexpression	53	Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) (Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%))	艱獵鏇獵廠範蓋膚製齋(築夢簾襯鏇襯鹹築鏇醖) = 鬱醖網餘鹽夢簾醖築鬱願齋簾鑰窪衊網鹽淵蓋 (蓋憲窪鑰製構顧選鏇蓋, 鹽壓衊鹽選糧選艱範鑰 ~ 遞蓋襯製廠鑰願齋積齋) 更多	-	2020-08-31
				Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) (Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%))	艱獵鏇獵廠範蓋膚製齋(築夢簾襯鏇襯鹹築鏇醖) = 製簾壓鹽艱觸築艱顧衊願齋簾鑰窪衊網鹽淵蓋 (蓋憲窪鑰製構顧選鏇蓋, 齋鹹艱淵鏇醖蓋鑰夢積 ~ 繭積醖艱衊鏇襯鹹鑰壓) 更多