科济药业宣布异体BCMA CAR-T CT0596初步临床数据，显示出良好的安全性和有效性-动脉网

CARsgen Announces Preliminary Clinical Data for Allogeneic BCMA CAR-T CT0596, Demonstrating Favorable Safety and Efficacy

CISION 等信源发布 2025-05-12 08:00

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May 11, 2025

2025年5月11日

/PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces preliminary clinical data for CT0596, an allogeneic BCMA-targeted CAR-T developed using the THANK-u Plus™ platform. CT0596 is currently being evaluated in an early exploratory clinical study for relapsed/refractory multiple myeloma (R/R MM) or relapsed/refractory plasma cell leukemia (R/R PCL) to assess its safety, and preliminary efficacy..

/PRNewswire/ -- 科济药业控股有限公司（股票代码：2171.HK），一家专注于开发创新CAR-T细胞疗法的公司，宣布了其使用THANK-u Plus™平台开发的同种异体BCMA靶向CAR-T产品CT0596的初步临床数据。CT0596目前正在进行一项早期探索性临床研究，用于评估复发/难治性多发性骨髓瘤（R/R MM）或复发/难治性浆细胞白血病（R/R PCL）患者的安全性及初步疗效。

As of

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May 6, 2025

2025年5月6日

, 8 patients with R/R MM who had received at least three prior lines of therapy were enrolled and infused with CT0596 following lymphodepletion with the FC regimen (fludarabine 22.5-30 mg/m² and cyclophosphamide 350-500 mg/m²). Key findings from up to four months of follow-up include:

，8名接受过至少三线前期治疗的R/R MM患者入组，并在使用FC方案（氟达拉滨22.5-30 mg/m²和环磷酰胺350-500 mg/m²）进行淋巴清除后，接受了CT0596输注。长达四个月随访的关键发现包括：

No dose-limiting toxicities (DLTs), ≥Grade 3 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or graft-versus-host disease (GVHD) were reported. The product demonstrated a favorable safety profile, with no patients discontinuing treatment due to adverse events..

未报告剂量限制性毒性（DLTs）、≥3级细胞因子释放综合征（CRS）、免疫效应细胞相关神经毒性综合征（ICANS）或移植物抗宿主病（GVHD）。该产品显示出良好的安全性，无患者因不良事件而停止治疗。

1) Among 5 patients who completed the first efficacy assessment at Week 4, 3 patients (60%) achieved stringent complete response/complete response (sCR/CR), and 4 patients (80%) achieved minimal residual disease (MRD)-negativity in the bone marrow. 2) Early efficacy data from 2 patients at Day 14 showed reductions in measurable lesions by ≥92% and ≥65%, respectively.

1) 在第4周完成首次疗效评估的5名患者中，3名患者（60%）达到了严格完全缓解/完全缓解（sCR/CR），4名患者（80%）在骨髓中实现了微小残留病（MRD）阴性。2) 第14天来自2名患者的早期疗效数据显示，可测量病灶分别减少了≥92%和≥65%。

3) 1 patient had not yet reached the protocol-specified efficacy assessment timepoint..

3) 1例患者尚未达到方案规定的疗效评估时间点。

All sCR/CR patients remained in ongoing responses, including the first patient who completed the four-month follow-up.

所有 sCR/CR 患者均保持持续缓解，包括第一个完成四个月随访的患者。

Based on the preliminary safety and efficacy data, CT0596 demonstrated favorable tolerability and encouraging efficacy signals in R/R MM patients across all predefined dose levels, with CAR-T expansion observed. These findings warrant further exploration not only in R/R MM, but also in other plasma cell malignancies and autoimmune diseases mediated by autoreactive plasma cells.

基于初步的安全性和有效性数据，CT0596 在所有预设剂量水平的复发/难治性多发性骨髓瘤（R/R MM）患者中表现出良好的耐受性和令人鼓舞的有效性信号，并观察到 CAR-T 扩增。这些发现不仅在 R/R MM 中值得进一步探索，在其他由自身反应性浆细胞介导的浆细胞恶性肿瘤和自身免疫疾病中也值得深入研究。

CARsgen plans to present detailed clinical data at upcoming scientific conferences. The company anticipates submitting an Investigational New Drug (IND) application .

科济药业计划在即将召开的科学会议上展示详细的临床数据，并预计提交新药临床试验（IND）申请。

for this product candidate in the second half of 2025.

对于该产品候选者，在2025年下半年。

About THANK-u Plus™

关于THANK-u Plus™

CARsgen has developed the THANK-u Plus™ platform as an enhanced version of its proprietary THANK-uCAR

科济药业开发了THANK-u Plus™平台，作为其专有的THANK-uCAR的增强版本。

allogeneic CAR-T technology to address the potential impact of NKG2A expression levels on therapeutic efficacy. THANK-u Plus™ demonstrates sustained expansion regardless of varying NKG2A expression levels on NK cells and exhibits significantly improved expansion compared to THANK-uCAR

同种异体CAR-T技术，以解决NKG2A表达水平对治疗效果的潜在影响。THANK-u Plus™展示出无论NK细胞上NKG2A表达水平如何变化，都能持续扩增，并且相较于THANK-uCAR表现出显著增强的扩增能力。

. Preclinical studies show that THANK-u Plus™ delivers superior antitumor efficacy in the presence of NK cells compared to THANK-uCAR

临床前研究表明，与THANK-uCAR相比，THANK-u Plus™在存在NK细胞的情况下具有更优越的抗肿瘤效果。

. Allogeneic BCMA or dual-targeting CD19/CD20 CAR-T cells developed using this platform exhibit robust antitumor activity in the presence of NK cells, indicating that THANK-u Plus™ has broad potential for developing diverse allogeneic CAR-T therapies. CARsgen is developing allogeneic CAR-T products using THANK-u Plus™ platform to increase CAR T cell expansion, persistence and efficacy..

使用该平台开发的同种异体BCMA或双靶向CD19/CD20 CAR-T细胞在NK细胞存在的情况下表现出强大的抗肿瘤活性，表明THANK-u Plus™在开发多种同种异体CAR-T疗法方面具有广泛的潜力。CARsgen正在使用THANK-u Plus™平台开发同种异体CAR-T产品，以提高CAR-T细胞的扩增、持久性和疗效。

About CARsgen Therapeutics Holdings Limited

关于科济药业控股有限公司

CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production.

CARsgen是一家生物制药公司，专注于开发创新的CAR T细胞疗法，以满足包括但不限于血液系统恶性肿瘤、实体瘤和自身免疫性疾病在内的未满足临床需求。CARsgen已经建立了涵盖靶点发现、临床前研究、产品临床开发以及商业化规模生产的CAR T细胞研发端到端的能力。

CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable..

CARsgen 开发了新颖的内部技术和具有全球权利的产品管线，以应对现有 CAR T 细胞疗法面临的挑战。努力包括提高安全性、增强治疗实体瘤的疗效以及降低治疗成本等。CARsgen 的使命是成为一家全球生物制药领域的领导者，为全世界患者提供创新且有差异化的细胞疗法，使癌症和其他疾病变得可治愈。

Forward-looking Statements

前瞻性声明

All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release.

本新闻稿中所有非历史事实或与当前事实或现状无关的陈述均为前瞻性陈述。此类前瞻性陈述表达了集团截至本新闻稿发布之日对未来事件的当前看法、预测、信念和期望。

Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur.

这些前瞻性陈述基于集团无法控制的许多假设和因素。因此，它们受到重大风险和不确定性的约束，实际事件或结果可能与这些前瞻性陈述以及本新闻稿中讨论的前瞻性事件存在重大差异，且这些前瞻性事件可能不会发生。

Such risks and uncertainties include, but are not limited to, those detailed under the heading 'Principal Risks and Uncertainties' in our most recent annual report and interim report and other announcements and reports made available on our corporate website, .

此类风险和不确定性包括但不限于我们在最新年报和中期报告中“主要风险和不确定性”标题下详细列出的内容，以及我们公司网站上发布的其他公告和报告。

https://www.carsgen.com

. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.

本新闻稿中包含的任何预测、目标、估计或预测，均不对其达成情况或合理性作出声明或保证，也不应依赖其作出决策。

Contact CARsgen

联系CARsgen

For more information, please visit

欲了解更多信息，请访问

https://www.carsgen.com/

SOURCE CARsgen Therapeutics

来源：CARsgen Therapeutics

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