AVC-203 is the world's first CRISPR-engineered allogeneic dual-targeting CD19/CD20 switchable CAR-T cell therapy to enter clinical testing

AVC-203是全球首个进入临床试验的CRISPR工程改造的同种异体双靶向CD19/CD20可切换CAR-T细胞疗法。

WATERTOWN, Mass.

马萨诸塞州沃特敦

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，

April 2, 2026

2026年4月2日

/PRNewswire/ -- AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic CAR-T cell therapies, today announced that it has dosed the first patient in the Phase I QUADvance study (AVC-203-01; NCT07284433) with AVC-203 for the treatment of relapsed/refractory B-cell malignancies..

/PRNewswire/ -- AvenCell Therapeutics, Inc.是一家领先的临床阶段细胞治疗公司，专注于推进可切换和同种异体CAR-T细胞疗法。该公司今日宣布，在针对复发/难治性B细胞恶性肿瘤的I期QUADvance研究（AVC-203-01；NCT07284433）中，已对首位患者使用AVC-203进行了给药。

AVC-203 is a CRISPR-engineered allogeneic CAR-T candidate designed to simultaneously target and eliminate cells expressing receptors CD19 and/or CD20, which are known to be expressed in nearly all B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL). The product incorporates a novel, dimerized receptor construct combining constitutive CD19/CD20 dual-targeting with AvenCell's proprietary RevCAR switchable receptor, enabling future indication flexibility and target expansion beyond CD19/CD20 through bi- or tri-specific bridging proteins..

AVC-203 是一种通过 CRISPR 技术改造的同种异体 CAR-T 候选产品，旨在同时靶向并消除表达 CD19 和/或 CD20 受体的细胞，这些受体几乎在所有 B 细胞恶性肿瘤中均有表达，包括弥漫性大 B 细胞淋巴瘤 (DLBCL)。该产品采用了一种新型的二聚化受体结构，将组成型 CD19/CD20 双重靶向与 AvenCell 专有的 RevCAR 可切换受体相结合，未来可通过双特异性或三特异性桥接蛋白实现适应症灵活性及超越 CD19/CD20 的靶向扩展。

'Patients with relapsed/refractory B-cell malignancies who have exhausted currently available treatment options, including approved autologous CAR-T therapies, have limited alternatives and a poor prognosis,' said Professor Martin Wermke, Head of the Early Clinical Trial Unit at the National Cancer Center Dresden, Germany.

“对于那些已经用尽当前所有可用治疗方案（包括已获批的自体CAR-T疗法）的复发/难治性B细胞恶性肿瘤患者来说，他们的选择非常有限，预后也很差，”德国德累斯顿国家癌症中心早期临床试验部门负责人马丁·韦尔姆克教授表示。

'AvenCell's allogeneic approach, combined with its innovative dual-targeting and switchable technology, represents a promising new therapeutic strategy for these patients.'.

“AvenCell的同种异体方法结合其创新的双靶向和可切换技术，为这些患者代表了一种有前景的新治疗策略。”

'Dosing the first patient with AVC-203 is a significant milestone for AvenCell and for the field of allogeneic cell therapy,' said Andrew Schiermeier, AvenCell's President & CEO. 'We are excited to build on the promising safety and activity observed in our ongoing allogeneic CAR-T clinical program in AML (AVC-201-01) by now entering B-cell lymphoma with what we believe to be the most scientifically compelling allogeneic technology in the industry.

“给第一名患者使用AVC-203是AvenCell以及同种异体细胞治疗领域的一个重要里程碑，” AvenCell总裁兼首席执行官Andrew Schiermeier表示，“我们很高兴在正在进行的针对AML（AVC-201-01）的同种异体CAR-T临床项目中观察到令人鼓舞的安全性和活性结果的基础上，现在进入B细胞淋巴瘤领域，我们相信这将是业内最具科学说服力的同种异体技术。”

AvenCell remains focused on ensuring that any patient who can benefit from CAR-T therapy can receive it, through the massive scaling of supply and dramatic reductions in cost of goods.'.

AvenCell 仍然专注于确保任何能够从 CAR-T 疗法中受益的患者都能通过大规模供应扩展和商品成本的大幅降低来获得治疗。

The AVC-203 program is supported by a grant of up to $40 million from the Japan Agency for Medical Research and Development ('AMED') (Project Name: 'Strengthening Program for Pharmaceutical Startup Ecosystem' R&D Project Title: 'Clinical development of bispecific allogeneic CAR-T cell therapy for CD19/CD20-positive relapsed/refractory B-cell lymphoma'), underscoring the global significance of AvenCell's allogeneic CAR-T platform.

AVC-203项目获得了日本医学研究开发机构（AMED）高达4000万美元的资助（项目名称：“医药初创企业生态系统强化计划”，研发项目标题：“针对CD19/CD20阳性复发/难治性B细胞淋巴瘤的双特异性同种异体CAR-T细胞疗法的临床开发”），凸显了AvenCell同种异体CAR-T平台的全球重要性。

The AMED grant will support the advancement of AVC-203 toward clinical development in Japan, with the goal of bringing this innovative therapy to patients across the Asia-Pacific region..

AMED 的资助将支持 AVC-203 在日本向临床开发的推进，目标是将这种创新疗法带给亚太地区的患者。

AvenCell received both FDA IND clearance and EMA approval of its Clinical Trial Application (CTA) for the QUADvance study on first submission in late 2025, enabling trial initiation at multiple sites in the US and Europe.

AvenCell在2025年底首次提交QUADvance研究的临床试验申请（CTA）后，获得了美国FDA的IND批准和欧洲EMA的批准，从而能够在美欧多个地点启动试验。

About AVC-203

关于AVC-203

AVC-203 is a CRISPR-engineered allogeneic CAR-T therapy incorporating four key innovations:

AVC-203是一种结合四项关键创新的CRISPR工程化同种异体CAR-T疗法：

Dual antigen targeting:

双抗原靶向：

AVC-203 CAR-T cells express a proprietary receptor that simultaneously targets CD19 and CD20.

AVC-203 CAR-T细胞表达一种同时靶向CD19和CD20的专利受体。

Immune evasion: AvenCell implements a unique, differentiated, and proprietary sequence of

免疫逃逸：AvenCell 实现了一种独特、差异化且专有的序列

CRISPR/Cas9 engineering to enable the use of healthy donor cell (versus the patient's own cells) to avoid both Graft-versus-Host Disease (GvHD) and rejection by the patient's immune system.

CRISPR/Cas9工程使得使用健康捐赠者的细胞（相对于患者自身的细胞）成为可能，从而避免移植物抗宿主病（GvHD）和患者免疫系统的排斥反应。

Improved T-cell fitness and off-the-shelf availability:

改进的T细胞适应性和现货供应：

A proprietary manufacturing process leverages the highly consistent T-cell fitness of healthy donors to eliminate the cost, variability, and complexity of patient-specific production, enabling immediate, massively-scalable treatment.

一种专有的制造工艺利用健康供体高度一致的T细胞适应性，消除了患者特异性生产的成本、可变性和复杂性，从而实现即时且可大规模扩展的治疗。

Switchable targeting:

可切换靶向：

A RevCAR receptor dimerized to the CD19/CD20 CAR enables flexible targeting of additional tumor antigens through bi- or tri-specific bridging proteins, allowing future target expansion beyond CD19/CD20.

RevCAR受体二聚化到CD19/CD20 CAR上，可以通过双特异性或三特异性桥接蛋白灵活靶向额外的肿瘤抗原，从而实现未来超越CD19/CD20的靶点扩展。

About AVC-203 Clinical Program

关于AVC-203临床项目

The QUADvance study (AVC-203-01) is a Phase I/II trial evaluating the safety, tolerability, efficacy, and pharmacokinetics of AVC-203 in adults with relapsed or refractory B-cell malignancies. The study is being conducted at multiple sites in the US and Europe, with planned expansion to Japan..

QUADvance 研究（AVC-203-01）是一项 I/II 期试验，评估 AVC-203 在复发或难治性 B 细胞恶性肿瘤成人患者中的安全性、耐受性、疗效和药代动力学。该研究正在美国和欧洲的多个地点进行，并计划扩展到日本。

About B-Cell Malignancies

关于B细胞恶性肿瘤

B-cell malignancies — including non-Hodgkin lymphomas, multiple myeloma, and B-cell acute lymphoblastic leukemia (B-ALL) — account for the majority of blood cancers. Approximately 120,000 and 150,000 new cases are diagnosed annually in the United States and Europe, respectively. While approved autologous CAR-T therapies have demonstrated meaningful clinical activity in certain B-cell malignancies, significant challenges remain, including lengthy manufacturing timelines, high costs, and limited accessibility.

B细胞恶性肿瘤——包括非霍奇金淋巴瘤、多发性骨髓瘤和B细胞急性淋巴细胞白血病（B-ALL）——占血液癌症的大多数。在美国和欧洲，每年分别约有12万和15万新病例被诊断。尽管已获批的自体CAR-T疗法在某些B细胞恶性肿瘤中显示出显著的临床活性，但仍然存在重大挑战，包括漫长的生产周期、高昂的成本和有限的可及性。

Allogeneic CAR-T therapies such as AVC-203 aim to address these limitations through off-the-shelf availability, consistent product quality, and scalable manufacturing..

同种异体CAR-T疗法（如AVC-203）旨在通过现成的可用性、一致的产品质量和可扩展的制造来解决这些局限性。

About AvenCell Therapeutics

关于AvenCell治疗学

AvenCell derives its name from the French word 'avenir' to reflect the aim to be the future of cell therapy. AvenCell is building a truly transformative cell therapy company that targets difficult-to-treat cancers, with its lead programs focusing on acute myeloid leukemia (AML) and B-cell malignancies, and additional programs targeting other hematological malignancies, auto-immune diseases, and solid tumors.

AvenCell 的名字源自法语单词“avenir”，旨在反映成为细胞治疗领域未来的愿景。AvenCell 正在打造一家真正具有变革性的细胞治疗公司，专注于难以治疗的癌症。其主要项目针对急性髓系白血病（AML）和B细胞恶性肿瘤，同时还有其他项目针对其他血液系统恶性肿瘤、自身免疫疾病和实体瘤。

AvenCell was formed with the goal to create truly allogeneic cells that persist as long or longer than autologous therapies and develop a universal and switchable construct that allows complete control and target redirection of T cells after they are infused into a patient. Integration of these two platforms allows for complete separation of the manufacturing of cells from ultimate patient and cancer target, thus providing significant scalability potential at orders of magnitude more efficient than current approaches..

AvenCell 成立的目标是创造持久性与自体疗法相当或更长的真正同种异体细胞，并开发一种通用且可切换的结构，使得在T细胞输入患者体内后能够完全控制和重新定向目标。这两个平台的结合使得细胞制造与最终患者和癌症目标完全分离，从而比当前方法效率高出几个数量级，具备显著的可扩展潜力。

Founded in 2021 by Blackstone Life Sciences, Cellex Cell Professionals, and Intellia Therapeutics, AvenCell incorporated the clinical-stage biopharmaceutical company GEMoaB GmbH. The company is headquartered in Watertown, Massachusetts, with research, clinical and manufacturing operations in Dresden, Germany..

AvenCell 由黑石生命科学、Cellex Cell Professionals 和 Intellia Therapeutics 于2021年创立，整合了临床阶段的生物制药公司 GEMoaB GmbH。公司总部位于美国马萨诸塞州沃特敦，并在德国德累斯顿设有研究、临床和制造业务。

For more information, please visit

更多信息，请访问

www.avencell.com

www.avencell.com

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Forward-Looking Statements

前瞻性声明

This press release contains 'forward-looking statements' of AvenCell Therapeutics, Inc. ('AvenCell' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding AvenCell's beliefs and expectations regarding: the safety, efficacy, success and advancement of its clinical programs for AVC-201 and AVC-203 for the treatment of hematological malignancies pursuant to their clinical trial applications, including the initiation, enrollment, dosing and completion of clinical trials, such as planned enrollment for the Phase 1 portion of the studies for AVC-201 and AVC-203..

本新闻稿包含AvenCell Therapeutics, Inc.（“AvenCell”或“公司”）根据1995年《私人证券诉讼改革法案》所定义的“前瞻性声明”。这些前瞻性声明包括但不限于AvenCell对其信念和期望的明确或隐含声明，涉及AVC-201和AVC-203在治疗血液系统恶性肿瘤方面的临床项目的安全性、有效性、成功及进展，依据其临床试验申请，包括临床试验的启动、招募、给药和完成，例如AVC-201和AVC-203研究第一阶段部分的计划招募。

Forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including AvenCell's ability to initiate, progress or complete pre-clinical or clinical studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional pre-clinical or clinical studies; uncertainties relating to regulatory applications and related filing and approval timelines; risks related to AvenCell's relationships and collaborations with third parties; risks related to the maintenance and protection of AvenCell's intellectual property; risks related to the potential successful development and commercialization of AvenCell's product candidates; and risks associated with AvenCell's understanding of cell therapy and its application to the treatment of cancers..

前瞻性声明涉及重大风险和不确定性，可能导致实际结果与这些声明所表达或暗示的内容存在重大差异。风险和不确定性包括（但不限于）研发中固有的不确定性，包括AvenCell能否在预期的时间内或完全启动、推进或完成临床前或临床研究，以及正在进行或额外的临床前或临床研究可能出现不利结果的可能性；与监管申请及其相关递交和批准时间表有关的不确定性；与AvenCell同第三方关系及合作相关的风险；与AvenCell知识产权的维护和保护相关的风险；与AvenCell产品候选者潜在成功开发和商业化相关的风险；以及与AvenCell对细胞疗法的理解及其在癌症治疗中的应用相关的风险。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements.

所有非历史事实的陈述都可能被视为前瞻性陈述。读者应注意，任何此类前瞻性陈述都不是未来业绩的保证，且涉及风险和不确定性，读者不应过分依赖这些前瞻性陈述。

All forward-looking statements are based on information currently available to AvenCell, and AvenCell assumes no obligation and disclaims any intent to update any such forward-looking statements..

所有前瞻性声明均基于AvenCell目前可获得的信息，AvenCell不承担任何义务，并拒绝更新任何此类前瞻性声明的意图。

Contact

联系

[email protected]

电子邮件地址

SOURCE AvenCell Therapeutics, Inc.

来源：AvenCell Therapeutics, Inc.

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