A Phase II Non-inferiority Study Comparing Point-of-care Produced CAR T-cell to Commercial CAR T-cells in Patients with Relapsed/refractory Non-Hodgkin Lymphoma

A phase II, multi-center study to compare the feasibility, and clinical efficacy of local manufacturing of CD19-directed CAR T-cells (ARI-0001 CAR T-cells) with commercial produced CAR T-cells (for example axicabtagene ciloleucel, a CD19 targeting commercially available CAR T-cell) in patients with relapsed or refractory (R/R) DLBCL.

开始日期2022-10-18

申办/合作机构

University Medical Center Groningen

[+1]

CTRI/2022/03/041162

/ Active, not recruiting临床2期

A phase 2 study to determine the safety and efficacy of IMN-003A cell therapy in patients with relapsed and refractory CD19 positive B cell malignancies - IMAGINE

开始日期2022-03-17

申办/合作机构

Immuneel Therapeutics Pvt Ltd.

NCT04778579

/ Active, not recruiting临床2期IIT

Phase 2 Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity (A3B1) Conjugated With the Co-stimulatory Regions 4-1BB and CD3z (ARI-0001 Cells) in Patients With CD19+ Acute Lymphoid Leukemia Resistant or Refractory to Therapy

To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated to the 4-aBB and CD3z co-stimulatory regions) in patients with resistant or refractory CD19+ acute lymphoid leukemia

开始日期2021-05-11

申办/合作机构

Institut d'Investigacions Biomèdiques August Pi i Sunyer

[+2]

100 项与法基奥仑赛相关的临床结果

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100 项与法基奥仑赛相关的转化医学

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100 项与法基奥仑赛相关的专利（医药）

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项与法基奥仑赛相关的文献（医药）

2025-04-01·Med

CD19 CAR-T cell therapy in a pediatric patient with MDA5+ dermatomyositis and rapidly progressive interstitial lung disease

Article

作者: Pertíñez, Lidia ; Ruiz de Valbuena, Marta ; de la Cruz-Benito, Ana ; Remesal, Agustín ; Galán-Gómez, Víctor ; Martínez-Romera, Isabel ; Dorao, Paloma ; Alcobendas-Rueda, Rosa M ; París-Muñoz, Andrés ; Cámara, Carmen ; González-Martínez, Berta ; Gómez-Zamora, Ana ; Ríos-Blanco, Juan J ; Minguillón, Jordi ; Udaondo, Clara ; Sánchez-Zapardiel, Elena ; Pérez-Martínez, Antonio ; Sanz-Rupérez, Alejandro ; Serrano-Olmedo, María G ; Del Pino-Molina, Lucía ; Fernández-García, Miguel A ; de Manuel-Gómez, Cristina ; Español-Rego, Marta ; Climent, Francisco ; Menéndez, Juan J ; Andrade, José D ; Verdú-Sánchez, Cristina ; Ruiz-Zurita, Gonzalo

BACKGROUND:

Anti-melanoma differentiation-associated protein 5 dermatomyositis (MDA5⁺DM) is a potentially fatal subtype of dermatomyositis. The most severe cases are characterized by rapidly progressive interstitial lung disease (RPILD), the leading cause of death in these patients. There is currently no curative treatment for these patients, and indeed, MDA5⁺DM-RPILD is considered one of the most challenging pathologies in medicine. Nevertheless, the recent introduction of CD19 chimeric antigen receptor (CAR)-T cell therapies appears to offer a serious opportunity to develop solutions for complex autoimmune diseases refractory to multiple immunosuppressant treatments, mainly rheumatic diseases such as rheumatoid arthritis, dermatomyositis, and systemic lupus erythematosus.

METHODS:

In this report, we describe the first use of a second-generation CD19 CAR-T cell therapy (ARI-0001) in a pediatric patient with severe MDA5⁺DM-RPILD.

FINDINGS:

Conventional treatments stabilized MDA5⁺DM-RPILD before CAR-T cell inoculation (-34 days). The presence of CD19⁺ B lymphocytes that might serve as target cells in deeper tissues was suspected due to CAR-T cell expansion in a context of B cell aplasia. No fever or cytokine release syndrome/cell-associated neurotoxicity syndrome was evident. In global terms, B cell reconstitution and cutaneous, motor, respiratory, and neurological improvements were observed gradually in the patient in an immunosuppressant-free context (-7 to +325 days).

CONCLUSIONS:

A pediatric patient with aggressive MDA5⁺DM-RPILD achieved progressive long-term improvement and immunosuppressant-free remission over 11 months after compassionate use of a CD19 CAR-T cell therapy (ARI-0001).

FUNDING:

This work was supported by the Programa Investigo (PI_SEPE_APM) and grants from the ISC-III (PI22/01226) from the Comunidad de Madrid (S2022/BMD-7225) and from the CRIS Cancer Foundation.

2025-02-17·BIOMARKERS

Role of procalcitonin, C-reactive protein and ferritin in cytokine release syndrome after CAR T-cell therapy in children and young adults

Article

作者: I, Jordan ; M, Caballero-Bellón ; S, Bobillo-Perez ; A, Alonso-Saladrigues ; A, Valls ; S, Rives ; A, Català

PURPOSE:

Chimeric antigen receptor (CAR) T-cell CD19 therapy has changed the treatment paradigm for patients with relapsed/refractory B-cell acute lymphoblastic leukemia. It is frequently associated with potentially severe toxicities: cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and admission to PICU is often required. Some biomarkers seem to correlate with CRS severity. Our goal is to elucidate the role of procalcitonin (PCT), C-reactive protein (CRP) and ferritin in the context of CRS following CAR T-cell infusion to predict its severity and PICU admission.

METHODS:

Prospective observational study (2016-2022) in children and young adult who received CAR T-cell therapy (Tisagenlecleucel/ARI-0001). We collected epidemiologic data, specific CAR T-cell toxicities, PICU admission, biomarker results (PCT, CRP and ferritin), length of stay and mortality. Biomarkers were analyzed considering two values: the highest value during ward admission, and the highest overall value including PICU admission.

RESULTS:

Seventy-seven patients were included. Median age at infusion was 9.1 years (IQR 6-13), 49.4% were females. Before CAR T-cell infusion, the median bone marrow blast was 9% (IQR 0-59). The most frequent toxicity was CRS in 62 patients (80.5%), it was severe in 18 cases (23.4%). Fourteen patients (18.1%) had ICANS. Thirty-one patients (40.3%) required admission to the PICU. PCT and ferritin were higher in patients admitted to PICU (PCT 0.8 ng/mL vs 0.15 ng/mL, p < 0.001, ferritin 5490 vs. 2900 µg/L, p < 0.019). The proposed cut-off for PCT to predict admission to PICU is 0.55 ng/mL, presenting a sensitivity of 67.7% and a specificity of 86.7%. The maximum value of three biomarkers was higher in those who presented any primary outcome: development of severe CRS, the need for admission to PICU, and in-hospital mortality. Biomarkers were higher in those who needed inotropic or respiratory support.

CONCLUSIONS:

PCT levels increase after CAR-T cell therapy in the setting of systemic inflammation and could be a predictor of PICU admission and evolution to death. Further research studying its role in the context of CRS and the differential diagnosis between infection and CRS is needed to better understand the biology of this biomarker and to define its value in clinical practice.

2024-02-01·British journal of haematology

The academic point‐of‐care anti‐CD19 chimeric antigen receptor T‐cell product varnimcabtagene autoleucel (ARI‐0001 cells) shows efficacy and safety in the treatment of relapsed/refractory B‐cell non‐Hodgkin lymphoma

Article

作者: Martínez-Cibrián, Núria ; Lozano, Miquel ; Sáez-Peñataro, Joaquín ; Benítez-Ribas, Daniel ; Blázquez, Andrea ; Rivero, Andrea ; Juan, Manel ; Olesti, Eulalia ; Varea, Sara ; Rodríguez, Sonia ; Cabezón, Raquel ; Giné, Eva ; Ortiz-Maldonado, Valentín ; Ayora, Pilar ; Español-Rego, Marta ; Urbano-Ispizua, Álvaro ; López-Guillermo, Armando ; Pascal, Mariona ; Castellà, Maria ; Rodríguez-Lobato, Luis Gerardo ; Cid, Joan ; González-Navarro, E Azucena ; Guillén, Elena ; Setoaín, Xavier ; Navarro, Sergio ; Brillembourg, Helena ; Delgado, Julio ; Magnano, Laura ; Montoro-Lorite, Mercedes ; Mozas, Pablo ; de Larrea, Carlos Fernández ; Correa, Juan G ; Sánchez-Castañón, María ; Alserawan, Leticia

Summary:

Varnimcabtagene autoleucel (var‐cel) is an academic anti‐CD19 chimeric antigen receptor (CAR) product used for the treatment of non‐Hodgkin lymphoma (NHL) in the CART19‐BE‐01 trial. Here we report updated outcomes of patients with NHL treated with var‐cel. B‐cell recovery was compared with patients with acute lymphoblastic leukaemia (ALL). Forty‐five patients with NHL were treated. Cytokine release syndrome (any grade) occurred in 84% of patients (4% grade ≥3) and neurotoxicity in 7% (2% grade ≥3). The objective response rate was 73% at Day +100, and the 3‐year duration of response was 56%. The 3‐year progression‐free and overall survival were 40% and 52% respectively. High lactate dehydrogenase was the only covariate with an impact on progression‐free survival. The 3‐year incidence of B‐cell recovery was lower in patients with NHL compared to ALL (25% vs. 60%). In conclusion, in patients with NHL, the toxicity of var‐cel was manageable, while B‐cell recovery was significantly prolonged compared to ALL. This trial was registered as NCT03144583.

项与法基奥仑赛相关的新闻（医药）

2025-07-28

·ETPharma

Cheaper cancer care therapy earns big bucks for pharma company

New Delhi: India's cell and gene therapy pioneer ImmunoAct has turned profitable in its first full year of operations, a rare feat in the country's emerging startup landscape where research-based pharma enterprises encounter serious scale and cash flow challenges. ImmunoACT, in which Hyderabad-based drugmaker Laurus Labs has roughly 34% equity stake, saw revenues of ₹62 crore with a profit before tax of ₹12 crore in FY25, according to sources. The year before, ImmunoAct had revenues of ₹11 crore. Founded by immunologist Rahul Purwar in 2013, ImmunoACT was spun off from the department of bioengineering department of IIT Bombay in 2018. ImmunoACT's NexCAR19 is the first indigenously developed breakthrough cancer CAR-T (chimeric antigen receptor T-cell) therapy approved by India's central drug regulatory agency in October 2023. NexCAR19 was formally launched in India in April 2024 at a price ~90% cheaper than its US and European counterparts like Novartis and Gilead, making it far more affordable for India and low-and-middle income countries, on its potential approval. So far, the therapy has been infused in over 350 patients across 70 hospitals in India. In CAR-T treatment, the patient's immune cells are extracted and through a maze of re-engineering processes infused back to recognize and kill cancer cells, giving a longer remission to patients as compared to the conventional options like immunotherapy or bone marrow transplants. The therapy is used when all other options are exhausted. Each CAR-T dose (one-and-done infusion) costs around ₹30 lakh, which was initially priced at ₹42 lakh, and is expected to see a further decline as demand picks up. Meanwhile, ImmunoACT has recently appointed former managing director of Roche India V Simpson Immanuel as its strategic advisor. Rahul Purwar added, "We needed someone who understands not just the commercial landscape, but also the nuances of innovation, patient access, and global expansion." Earlier this year, Immuneel Therapeutics, backed by leading names like Kiran Mazumdar-Shaw and globally renowned oncologist Siddhartha Mukherjee secured approval for Qartemi, its cell therapy for adult B-cell non-Hodgkin Lymphoma, in India. Companies like Cipla , Dr Reddy's Labs and Bharat Biotech are investing heavily in new CAR-Ts. Globally, CAR-Ts are at the frontiers of a range of cancer treatments, attracting billions of dollars in investments from large drugmakers. The market for such therapies is expected to touch $134 billion by 2034 from around $10 billion at present. By Vikas Dandekar ,

免疫疗法上市批准细胞疗法

2025-06-15

·生物制品圈

亚洲生物制造的崛起：全球生物生产布局的新机遇与范式变革

在全球生物经济格局深刻调整的当下，亚洲正以令人瞩目的速度重塑世界生物制造版图。这一区域的崛起绝非偶然，而是多重历史机遇与现实条件共同作用的结果。从东京湾沿岸的现代化生物制药园区，到印度半岛蓬勃发展的生物制造集群，再到波斯湾地区崭露头角的新兴产能中心，亚洲正通过技术创新、产能扩张与生态构建，逐步成为全球生物生产体系的核心支柱。发展脉络与驱动机制：历史逻辑与现实推力的交织亚洲生物制造领域的增长轨迹呈现出显著的阶段性特征。根据 BioPlan Associates 发布的 "全球前 1000 家生物设施指数" 及生物制造数据库的长期追踪数据，中国与印度的生产能力扩张早在新冠疫情爆发前已持续十余年。这种长期增长本质上是产业升级的必然结果 —— 从最初专注于仿制小分子药物的生产，逐步向生物类似药、疫苗乃至细胞基因治疗等复杂生物制品领域延伸。值得注意的是，疫情危机客观上成为加速这一进程的催化剂，全球供应链的脆弱性迫使各国重新审视区域产能战略，而亚洲在危机中展现出的生产韧性，进一步强化了其作为全球生物制造基地的战略价值。深入分析这一发展进程的驱动因素，可归纳为三重维度的协同作用：在成本要素层面，亚洲地区劳动力与土地等基础生产要素的成本优势，使其在规模化生产中具备天然竞争力；在政策环境层面，各国政府普遍将生物产业列为战略性新兴产业，通过税收优惠、研发补贴、监管优化等组合拳，构建了有利于产业发展的制度环境；在技术能力层面，经过多年积累，亚洲企业已从单纯的产能提供者，逐步成长为具备全链条技术整合能力的解决方案供应商。这种综合优势在当前地缘政治格局下更显珍贵 —— 当美国联邦政府对进口商品 "对等关税" 政策的不确定性持续扰动全球市场时，亚洲，尤其是印度等基础设施与市场体系日臻完善的地区，反而成为跨国企业规避政策风险、实现产能多元化布局的优选之地。区域实践与创新突破：国家案例的多维透视日本：技术精进与产能升级的双轮驱动日本生物制造产业的发展呈现出典型的 "技术密集型" 特征。AGC Biologics 在横滨工厂的扩建计划颇具代表性，该公司正投资 500 亿日元（约 3.25 亿美元）建设总面积达 2 万平方米的新生产设施，其核心竞争力体现在对一次性生物反应器技术的规模化应用上。值得关注的是，该项目最终确定采用 Thermo Fisher Scientific 的两套 5000L HyPerforma DynaDrive 系统，较最初规划的 2000L 和 4000L 设备实现了技术跃升。这种选择绝非偶然，而是基于对生产成本与工艺灵活性的综合考量 ——Thermo Fisher 的技术方案可通过减少设备投资、耗材消耗及人工成本，将生产费用降低达 25%，这种 "性价比革命" 正是日本企业在全球竞争中保持优势的关键。Kyowa Kirin 的产能扩张则展现了另一种战略路径 —— 通过全球化生产网络的构建实现技术与市场的双重渗透。该公司在高崎生产基地投资 168 亿日元（约 1.18 亿美元）新建的原液工厂，不仅采用一次性使用技术以降低产品交叉污染风险，更前瞻性地预留了连续生产、自动化及数字化等先进工艺的导入空间。这种 "硬件建设与柔性升级" 并重的理念，与其在美国北卡罗来纳州桑福德新建工厂形成协同效应，共同构成了覆盖研发、生产到市场的全链条全球化体系。特别值得一提的是，Kyowa Kirin 于 2024 年 7 月加入 "医药供应链倡议组织"（PSCI），这一举措标志着日本企业已从单纯的生产能力建设，转向对整个医药供应链可持续性的战略布局。印度：从成本优势到技术引领的跨越发展印度生物制造产业的崛起堪称近年来全球生物经济领域最引人注目的现象之一。Shilpa Medicare 的 CDMO 业务拓展轨迹清晰展现了这一进程 —— 该公司自 2016 年收购 Navya Biologicals 以来，持续在生物制药产能建设上发力，从最初专注于重组人血清白蛋白的大体积微生物发酵，到疫情后快速搭建哺乳动物细胞培养的疫苗生产能力，直至 2025 年正式宣布进军 CDMO 领域，完成了从原料药生产商到全链条解决方案供应商的蜕变。其正在建设的 20 万升微生物发酵工厂，一旦于 2025 年底投入使用，将成为印度最大、全球 CDMO 领域微生物产能领先的设施之一，这种规模化能力使其在胰岛素、GLP-1 类产品等市场需求旺盛的领域占据先机。Enzene 的国际化布局则体现了印度企业在技术标准与市场准入方面的突破。该公司位于浦那的两处工厂通过欧洲药品管理局（EMA）GMP 认证，标志着其生产体系已达到全球最高监管标准，为进入欧美主流市场铺平了道路。Enzene 的核心竞争力在于其 EnzeneX 2.0 平台，该平台基于全连接连续生产（FCCM）技术，通过集成自动化、机器学习与人工智能技术，可将生产成本降低达 50%。这种 "技术降本" 模式使其在全球生物制药成本控制竞赛中占据独特地位。值得注意的是，作为 Alkem Laboratories 的子公司，Enzene 已在美国新泽西州建立生产基地，并计划未来两年内实现六条生产线全部投产，这种 "印度技术 + 美国布局" 的模式，正在重塑全球生物制造的地理经济学。Bharat Biotech 在细胞与基因治疗（CGT）领域的突破，标志着印度生物制造已从传统生物药向前沿治疗领域进军。该公司在海得拉巴基因谷启用的 7500 万美元 CGT 工厂，专注于腺相关病毒（AAV）、慢病毒（LV）等病毒载体的高滴度生产，这一举措具有战略前瞻性 —— 病毒载体作为细胞与基因疗法的 "运输工具"，其生产能力直接制约着整个 CGT 产业的发展。Bharat Biotech 的布局并非孤立事件，印度在 CGT 领域已形成初步的生态体系：从 2021 年孟买塔塔医院完成首例 CAR-T 细胞治疗临床试验，到 2023 年 ImmunoACT 旗下 NexCAR19 获批上市，再到 2025 年 Immuneel Therapeutics 的个性化 CAR-T 疗法 Qartemi 获得批准，印度正在构建从技术研发到临床应用的完整产业链。中东：新兴力量的战略布局与模式创新波斯湾国家在生物制造领域的崛起呈现出独特的 "资源驱动 + 创新导入" 模式。阿联酋 Burjeel 控股与美国非营利组织 Caring Cross 的合作颇具代表性，双方计划在阿布扎比建立符合 GMP 标准的 CAR-T 疗法生产设施，这一项目的战略意义在于其试图破解先进疗法 "可及性困境"—— 通过去中心化、近端制造的模式，将 CAR-T 疗法的生产基地贴近患者所在地，避免集中生产模式下的后勤与商业加价成本。Burjeel 血液肿瘤及细胞治疗中心主任 Ajlan Al Zaki 指出，该设施将具备同时处理 200 个样本的能力，实现细胞产品的本地交付，这种 "本地化生产 + 全球化协作" 的模式，与阿联酋打造区域先进生物制造中心的长期愿景高度契合。Andrew Harmon 在 2025 年 BioProcess International West 会议上的判断颇具洞察力 —— 他认为中东国家在疫情后制造业中心变迁中有望蓬勃发展，这一论断的依据在于中东国家正通过系统性投资构建竞争优势：在监管环境方面，阿联酋等国正致力于营造灵活高效的政策环境；在人才储备方面，通过与国际机构合作培养专业技术人才；在技术导入方面，积极引进全球前沿技术并推动本地化转化。Caring Cross 首席执行官 Boro Dropulić强调的 "医疗公平" 理念，更是为中东生物制造发展注入了独特的价值内涵 —— 通过技术创新与模式创新，让高价先进疗法变得可及，这种发展路径不同于传统的成本竞争或技术竞赛，而是开辟了生物制造价值创造的新维度。未来展望：机遇与挑战并存的发展新图景亚洲生物制造的崛起正在引发全球生物生产体系的结构性变革。从产业格局看，这一进程打破了欧美长期主导的单极格局，形成了多中心协同发展的新格局；从技术路径看，亚洲企业正在从技术跟随者逐步成长为创新引领者，尤其是在一次性生产技术、连续生产工艺、数字化制造等领域，已形成独特的技术优势；从市场逻辑看，亚洲正从单纯的生产基地，转变为集研发、生产、市场于一体的综合性生物经济区域。然而，在看到机遇的同时，也需清醒认识到挑战的存在。在技术层面，高端生物药生产所需的关键设备、耗材仍高度依赖进口，"卡脖子" 风险不容忽视；在监管层面，如何在加速创新与确保安全之间取得平衡，仍是各国监管机构面临的难题；在全球竞争层面，亚洲各国之间也存在一定的同质化竞争倾向，如何通过差异化定位构建协同发展生态，是区域产业可持续发展的关键。展望未来，亚洲生物制造的发展将呈现三大趋势：一是技术融合加速，生物技术与信息技术、材料技术的深度融合，将催生更多颠覆性创新；二是产业生态重构，从单一企业竞争转向产业集群竞争，区域内的分工协作将更加紧密；三是价值维度拓展，生物制造将不再局限于产品生产，而是向医疗服务、健康管理等价值链高端延伸。在这一进程中，亚洲有潜力成为全球生物经济变革的引领者，为解决人类健康难题提供 "亚洲方案"。原文来源：J.Abbott, S.Ojha, D.Stanton, et al, Emerging Capacity in Asia : Opportunities Blossom for Establishing Global Bioproduction Capabilities. Bioprocess Insider, 2025.识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

生物类似药疫苗核酸药物

2025-06-10

·PRNewswire

ScaleReady Announces a G-Rex® Grant has been awarded to Immuneel Therapeutics

ST. PAUL, Minn., June 10, 2025 /PRNewswire/ -- ScaleReady, in collaboration with Wilson Wolf Manufacturing, Bio-Techne Corporation and CellReady, today announced that Immuneel Therapeutics has been awarded a $150,000 G-Rex® Grant to support process development aimed at enhancing the scalability and cost-effectiveness of CAR-T cell manufacturing in India. "The blood cancer burden on India's population is substantial, around 120,000 new cases of lymphoma, leukemia, and multiple myeloma are diagnosed each year. Unfortunately, almost 70,000 Indians will die every year from these afflictions, devastating the lives of their families and communities. To afford access to all Indian patients in need, and to capitalize on the immense commercial potential of our pipeline, we need to think prudently and practically about our manufacturing approach. In the short term, our manufacturing demands are almost 200 drug products per day, and this may increase as CAR-T cell therapies move closer to front line treatment. The only practical way for us to industrialize our production and produce a supply of drug product commensurate with total patient demand is to transition to G-Rex," said Dr. Lakshmikanth Gandikota, Head of R&D, MSAT Intellectual Property, and Translational Research, at Immuneel Therapeutics Limited. "We are extremely impressed by the speed, resourcefulness, creativity, discipline, and entrepreneurialism of the team at Immuneel and are happy to see that India, as a whole, is making significant strides toward CAR-T availability. It gives us a great sense of satisfaction to be in a position to help bring hope to cancer patients in India, one G-Rex at a time," said John Wilson, CEO of Wilson Wolf and co-inventor of G-Rex. As part of Immuneel's G-Rex Grant, they will perform process development, qualification, and validation of a G-Rex based CAR-T cell therapy production approach to dramatically increase the throughput capacity of their state-of-the-art, 12,000 square foot GMP facility. Located in Bengaluru and opened in 2021, Immuneel's Integrated Cell Therapy Development and Manufacturing Facility was the first of its kind in India and is designed to bring breakthrough cell and gene therapies to millions of patients in India. Lastly, Immuneel's G-Rex Grant will support the requisite comparability studies necessary to support a post-CAR-T approval manufacturing change from their difficult to scale low throughput all-in-one manufacturing equipment to a much simpler high throughput G-Rex centric approach. The high popularity of ScaleReady's G-Rex Grant Program led ScaleReady to increase award funds from the original amount of $20M to a total of $30M directed towards saving recipients significant time and money by expediting the path to optimized cell and gene-modified cell therapy manufacturing. Two hundred grants have already been awarded with over 50 new applications in the queue. Each G-Rex Grant recipient can obtain up to $300,000 and gain access to exclusive support from ScaleReady's growing consortium of G-Rex Grant Partners who bring best-in-class tools and technologies as well as unparalleled knowledge and expertise in the areas of cGMP manufacturing, quality and regulatory affairs, CGT business operations, and more. For more information about the G-Rex® Grant Program, please contact [email protected] . About ScaleReady ScaleReady provides the field of cell and gene-modified cell therapy (CGT) with a G-Rex centric manufacturing platform that enables the world's most practical, flexible, scalable, and affordable CGT drug product development and manufacturing. The G-Rex manufacturing platform is currently used by a rapidly growing list of over 800 organizations and is producing drug products for approximately 50% of CGT clinical trials as well as 5 commercially approved CGT drugs. CGT entities relying on the breadth and scope of ScaleReady's expertise can expect to save years of time and millions of dollars on the path to CGT commercialization. For more information about the ScaleReady G-Rex® Grant Program, please contact [email protected]. About Wilson Wolf Manufacturing Wilson Wolf () is dedicated to simplifying cell and gene-modified cell (CGT) therapy research, process development, and manufacturing. This is being accomplished through its scalable G-Rex technology, which is used throughout the world in CGT applications ranging from basic research to commercial drug production. Wilson Wolf's mission is to create hope for cancer patients, one G-Rex® device at a time. About Bio-Techne Corporation Bio-Techne Corporation (NASDAQ: TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne, in partnership with Wilson Wolf, is creating products such as media and cytokines that are specifically tailored to G-Rex® Bioreactors, including right-sized reagent quantities in containers that are tailored to high throughput closed-system manufacturing. For more information on Bio-Techne and its brands, please visit or follow the Company on social media at: Facebook, LinkedIn, Twitter or YouTube. Contact: David Clair, Vice President, Investor Relations & Corporate Development [email protected] 612-656-4416 About CellReady LLC CellReady is the world's first and only G-Rex centric contract development and manufacturing organization (CDMO) specializing in G-Rex based cell and gene-modified cell therapy development and manufacturing. The company offers a wide range of services to support the development and commercialization of these therapies. CellReady's mission is to create hope for cancer patients, one G-Rex® process at a time. About Immuneel therapeutics Private Limited Immuneel Therapeutics Private Limited is a cutting-edge biotechnology company based in Bangalore, India, at the forefront of advancing cell and gene therapies, as well as personalized immunotherapies, for cancer patients in India. As a research-driven and fully integrated organization, Immuneel is dedicated to making next-generation cancer treatments accessible and affordable, with a strong focus on innovation and clinical impact. The company's mission is to democratize advanced therapies by developing and commercializing breakthrough solutions tailored to the needs of Indian patients. As part of its growing portfolio, Immuneel has licensed and commercialized Qartemi® (varnimcabtagene autoleucel), a CD19 CAR-T cell therapy approved by India's Central Drugs Standard Control Organization (CDSCO) for the treatment of adult B-cell non-Hodgkin lymphoma a novel therapy for blood cancer, further demonstrating its commitment to transforming cancer care in India. Immuneel has a robust pipeline of CAR-T therapies for various indications in Oncology and AutoImmune diseases For more information, please visit: SOURCE Bio-Techne Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

免疫疗法细胞疗法基因疗法临床研究

100 项与法基奥仑赛相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
非霍奇金淋巴瘤	印度	Immuneel Therapeutics Pvt Ltd.	2025-01-20
急性淋巴细胞白血病	西班牙	Instituto De SAlud Carlos Iii De Madrid	2021-02-10

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适应症	最高研发状态	国家/地区	公司	日期
CD19阳性急性淋巴细胞白血病	临床2期	西班牙	Instituto De SAlud Carlos Iii De Madrid	2021-05-11
CD19阳性急性淋巴细胞白血病	临床2期	西班牙	Institut d'Investigacions Biomèdiques August Pi i Sunyer	2021-05-11
CD19阳性B细胞白血病	临床1期	西班牙	Institut d'Investigacions Biomèdiques August Pi i Sunyer	2017-06-15
CD19阳性B细胞白血病	临床1期	西班牙	Instituto De SAlud Carlos Iii De Madrid	2017-06-15
CD19阳性淋巴瘤	临床1期	西班牙	Institut d'Investigacions Biomèdiques August Pi i Sunyer	2017-06-15
CD19阳性淋巴瘤	临床1期	西班牙	Instituto De SAlud Carlos Iii De Madrid	2017-06-15
皮肌炎	临床阶段不明	西班牙	Hospital Universitario La Paz	2025-04-29

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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


CTRI/2022/03/041162 (IMAGINE study, EHA2025)	临床2期	CD19	24	Varnimcabtagene autoleucel	齋膚蓋範鏇鬱淵範艱積(憲積艱蓋糧製築築鹽鹽) = 繭廠襯艱膚構憲壓築淵憲範網鹹膚簾壓廠繭遞 (觸鏇顧衊壓蓋顧鏇壓膚 ) 更多	积极	2025-05-14
NCT03144583 (EHA2024) 人工标引	临床1期	滤泡性淋巴瘤 CD19 Positive	21	ARI-0001btagene autoleucel (var-cel)	衊範構獵範憲憲艱蓋襯(壓鹹顧選襯憲製鬱廠選) = 選獵鹹廠膚鹽鑰範憲構築餘鏇鑰糧繭廠壓顧鬱 (積網淵蓋鏇衊衊繭齋願, 70 ~ 99) 更多	积极	2024-05-14
ARI-0001 (EHA2024) 人工标引	N/A	B细胞淋巴瘤 CD19 ... 更多	58	ARI-0001	顧壓觸遞鬱範衊網構膚(積窪鏇窪廠構壓鬱襯範) = 醖鹹鹽夢蓋網鑰構繭願範夢築餘齋鹹製廠簾觸 (構餘艱鏇網構網衊糧糧 ) 更多	积极	2024-05-14
ASH2023	N/A	慢性淋巴细胞白血病 \| 里氏综合症	20	Varnimcabtagene Autoleucel (ARI-0001) (Varnimcabtagene Autoleucel (var-cel))	築觸蓋憲觸襯鹹觸餘積(簾簾構顧鑰構糧簾膚網) = 鹹範積淵鏇範憲襯積鹽窪鹹構蓋鏇繭構網夢繭 (構衊顧築夢糧製獵製築 ) 更多	-	2023-12-10
CTRI/2022/03/041162 (IMAGINE, ASH2023)	临床2期	B细胞恶性肿瘤	25	Varnimcabtagene autoleucel (IMN-003A)	製顧積鏇網顧醖窪襯積(艱壓膚鑰鬱齋製淵廠繭) = 範觸醖觸淵顧顧夢憲蓋襯艱構淵簾鬱壓糧顧鏇 (窪膚衊窪衊積觸膚選鑰 ) 更多	积极	2023-12-09
CTRI/2022/03/041162 (IMAGINE, ICML2023)	临床2期	B细胞恶性肿瘤 CD19	23	Varnimcabtagene autoleucel (IMN-003A)	餘鹹範鑰範壓齋顧壓選(構蓋廠網獵餘蓋選齋齋) = 窪願壓鏇憲繭製築鏇壓齋夢獵夢觸憲顧醖簾窪 (廠構壓廠鏇廠淵網壓繭 ) 更多	积极	2023-06-09
NCT03144583 (CART19-BE-01, EHA2023)	临床1期	CD19 表达恶性肿瘤 \| 白血病	51	Varnimcabtagene autoleucel (var-cel)	築醖願鬱簾衊淵憲齋願(艱築網廠衊淵艱壓襯齋) = 窪艱糧繭憲膚廠鹹餘鬱窪觸鬱憲壓廠簾鬱廠齋 (壓膚願壓壓繭選觸壓淵, 49 ~ 78) 更多	-	2023-06-08
CTRI/2022/03/041162 (EHA2023)	临床2期	急性淋巴细胞白血病 \| 非霍奇金淋巴瘤	22	IMN-003A	糧齋齋築網蓋艱顧齋選(鏇鑰願鬱網遞蓋廠蓋齋) = 餘鑰蓋憲夢獵艱範選襯繭願鏇夢鏇齋簾製選鑰 (繭鹹選選齋糧艱願鹽獵 ) 更多	-	2023-06-08
CTRI/2022/03/041162 (IMAGINE, ASH 12022 \| ASH 22022) 人工标引	临床2期	B细胞淋巴瘤	8	IMN-003A	築築積鹽顧衊觸艱選鏇(築憲膚壓鹹網築廠餘鹽) = 8 pts (CRS (Grade [G] 1 50%; G3+ 0%; overall 50%), neutropenia (G3+ 50%; overall 62.5%), anemia (G3+ 0%; overall 62.5%), and thrombocytopenia (G3+ 0%; overall 62.5%)) 衊廠製鹽艱獵願選選鏇 (壓鹽簾鏇觸鏇簾壓糧襯 )	积极	2022-11-15
EHA2021	N/A	-	53	ARI-0001	鹹鑰淵膚醖網構衊襯壓(鹹壓憲遞遞鏇獵繭遞夢) = 鬱壓艱廠衊願艱願蓋範範願簾遞衊鏇齋觸廠鏇 (積鏇鏇鬱網窪鑰艱築窪, 38.4 ~ 67.4) 更多	-	2021-06-09