Phase 1b study suggests a promising safety profile and highlights the potential of a novel dual-targeting CD19/CD20 CAR T in patients with relapsed or refractory disease

1b期研究显示出了令人鼓舞的安全性，并突显了新型双靶向CD19/CD20 CAR T在复发或难治性疾病患者中的潜力。

75-80% complete response rate among evaluable patients at the recommended Phase 2 dose

在推荐的二期剂量下，可评估患者中有75-80%的完全缓解率

MILAN

米兰

,

，

June 13, 2025

2025年6月13日

/PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today the first clinical data from an ongoing Phase 1b study for JNJ-90014496 (JNJ-4496), an investigational dual-targeting anti-CD19/CD20 bispecific autologous chimeric antigen receptor (CAR) T-cell therapy, being studied in patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) who have not been previously treated with CAR T-cell therapy..

/PRNewswire/ -- 强生公司（纽约证券交易所代码：JNJ）今天宣布了正在进行的JNJ-90014496（JNJ-4496）一期临床试验的首批数据，这是一种研究性的双靶向抗CD19/CD20双特异性自体嵌合抗原受体（CAR）T细胞疗法，正在针对未接受过CAR T细胞治疗的复发或难治性大B细胞淋巴瘤（R/R LBCL）患者中进行研究。

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Findings demonstrate the potential of JNJ-4496 in the treatment of patients with R/R LBCL, including R/R diffuse large B-cell lymphoma (DLBCL) – the most common type of aggressive lymphoma, a blood cancer that originates in the lymphatic system.

研究结果表明，JNJ-4496在治疗R/R LBCL患者（包括R/R弥漫性大B细胞淋巴瘤（DLBCL））方面具有潜力。DLBCL是最常见的侵袭性淋巴瘤类型，是一种起源于淋巴系统的血液癌症。

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These data were presented as an oral presentation at the

这些数据在一场口头报告中被展示。

2025 European Hematology Association (EHA) Congress

2025年欧洲血液学协会（EHA）大会

(

(

Abstract #S239

摘要 #S239

).

）。

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JNJ-4496, formerly known as C-CAR039, is a dual-targeting CAR T designed to bind to both CD19 and CD20 antigens — two cell surface proteins commonly expressed on malignant B-cells. This design, including a 4-1BB costimulatory domain, is intended to enhance binding strength and persistence, also potentially addressing common mechanisms of resistance in relapsed or refractory disease..

JNJ-4496，以前称为C-CAR039，是一种双靶向CAR T细胞疗法，旨在结合CD19和CD20抗原——这两种常在恶性B细胞上表达的表面蛋白。该设计包括一个4-1BB共刺激域，旨在增强结合强度和持久性，同时可能解决复发或难治性疾病中常见的耐药机制。

In the Phase 1b dose confirmation study (

在1b期剂量确认研究中 (

NCT05421663

NCT05421663

) in patients with R/R LBCL, data at the recommended Phase 2 dose (RP2D) were reported in patients with a median follow-up of 4 months. Results informed a RP2D of JNJ-4496 at 75 million CAR+ T-cells. Among the 22 patients in the RP2D group where efficacy was assessed, those who received one prior line of therapy (n=10) had an objective response rate (ORR) of 100 percent and a complete response rate (CRR) of 80 percent (95 percent confidence interval (CI), 69, 100).

在R/R LBCL患者中，推荐的二期剂量（RP2D）下报告了中位随访时间为4个月的患者数据。结果确定了JNJ-4496的RP2D为7500万个CAR+ T细胞。在RP2D组中评估疗效的22名患者中，接受过一种前期治疗的患者（n=10）客观缓解率（ORR）为100%，完全缓解率（CRR）为80%（95%置信区间（CI），69，100）。

In the patients who had received two or more prior lines of therapy (n=12), the ORR was 92 percent and the CRR was 75 percent (95 percent CI, 62, 100)..

在既往接受过两种或以上治疗方案的患者（n=12）中，总缓解率（ORR）为92%，完全缓解率（CRR）为75%（95%置信区间：62%，100%）。

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'There is a pressing need to continue advancing therapies for patients with relapsed or refractory diffuse large B-cell lymphoma. Only about 40 percent of patients have long-term remissions with currently available single-antigen-targeting CD19 CAR T therapies,' said Krish Patel*, M.D., Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), and principal study investigator.

“对于复发或难治性弥漫性大B细胞淋巴瘤患者，继续推进治疗方案存在迫切需求。目前可用的单抗原靶向CD19 CAR T疗法中，仅有约40%的患者能够获得长期缓解，”Sarah Cannon研究所（SCRI）淋巴瘤研究主任兼主要研究负责人Krish Patel医学博士表示。

'The data presented today show encouraging clinical activity and promising safety, and represent a step forward in delivering a potential new treatment option to patients living with the most common type of aggressive lymphoma.'.

“今天提供的数据显示出令人鼓舞的临床活性和可靠的安全性，代表着在为最常见的侵袭性淋巴瘤患者提供新的治疗选择方面迈出了重要一步。”

Within the RP2D safety group (n=25), 52 percent of patients (n=13) received two or more prior lines of therapy, and 56 percent (n=14) received bridging therapy. In the RP2D cohort studied, no cases of Grade 3 or 4 cytokine release syndrome were observed. Two patients had immune effector cell-associated neurotoxicity syndrome (ICANS), one Grade 1 and one Grade 3.

在RP2D安全组（n=25）中，52%的患者（n=13）接受了两线或多线既往治疗，56%的患者（n=14）接受了桥接治疗。在所研究的RP2D队列中，未观察到3级或4级细胞因子释放综合征病例。两名患者出现免疫效应细胞相关神经毒性综合征（ICANS），分别为1级和3级。

The Grade 3 event occurred in a patient with central nervous system (CNS) lymphoma. Overall, 84 percent of patients (n=21) had Grade 3/4 treatment-emergent adverse events (TEAEs), and 28 percent (n=7) reported serious TEAEs. The most common Grade 3/4 TEAE was neutropenia, a reduction in white blood cells (72 percent).

3级事件发生在一名中枢神经系统（CNS）淋巴瘤患者中。总体而言，84%的患者（n=21）发生了3/4级治疗相关不良事件（TEAEs），28%的患者（n=7）报告了严重的TEAEs。最常见的3/4级TEAE是中性粒细胞减少症，即白细胞减少（72%）。

One patient experienced a Grade 3 infection..

一名患者经历了3级感染。

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'We're really excited to share the first results for our dual-targeting anti-CD19/CD20 CAR T-cell therapy in relapsed or refractory large B-cell lymphoma, underscoring our more than decade-long commitment to addressing unmet needs for patients with B-cell malignancies,' said Jeffrey Infante, M.D., Vice President of Early Clinical Development and Translational Research at Johnson & Johnson Innovative Medicine.

“我们非常激动地分享了我们的双靶向抗CD19/CD20 CAR-T细胞疗法在复发或难治性大B细胞淋巴瘤中的首个结果，这体现了我们十多年来致力于满足B细胞恶性肿瘤患者未满足需求的承诺，”约翰逊创新医药公司早期临床开发与转化研究副总裁Jeffrey Infante博士表示。

'As we continue to unlock the full potential of CAR T-cell therapies through novel next-generation approaches, these promising data reinforce earlier long-term findings and highlight the potential of JNJ-4496 to improve outcomes for patients.'.

“随着我们通过新型的下一代方法继续充分释放CAR T细胞疗法的潜力，这些令人鼓舞的数据巩固了早期的长期研究结果，并突显了JNJ-4496改善患者预后的潜力。”

These data are advancing our pipeline of CAR T therapies for the treatment of B-cell malignancies and are an extension of our worldwide collaboration and licensing agreement initiated with AbelZeta Inc. (formerly Cellular Biomedicine Group, Inc.) in 2023 to develop and commercialize next-generation CAR T-cell therapies (excluding Greater China).

这些数据正在推动我们用于治疗 B 细胞恶性肿瘤的 CAR T 疗法管线，并且是我们于 2023 年与 AbelZeta Inc.（前身为 Cellular Biomedicine Group, Inc.）启动的全球合作和许可协议的延伸，以开发和商业化下一代 CAR T 细胞疗法（不包括大中华地区）。

A Phase 1 study for C-CAR039 was conducted in China for the treatment of patients with B-cell non-Hodgkin lymphoma (predominantly LBCL)..

在中国进行了一项C-CAR039的I期研究，用于治疗B细胞非霍奇金淋巴瘤（主要是LBCL）患者。

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Johnson & Johnson is also evaluating the safety and efficacy of this asset (known as JNJ-4496 outside of Greater China) through a separate study involving a global patient population.

强生公司也正在通过一项涉及全球患者群体的独立研究，评估该资产（在大中华区以外地区称为 JNJ-4496）的安全性和有效性。

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In addition to the oral presentation of JNJ-4496 at EHA, the global clinical study data will be presented at the 2025 International Conference on Malignant Lymphoma from June 17—21.

除了在EHA上口头报告JNJ-4496外，全球临床研究数据还将于2025年6月17日至21日举行的国际恶性淋巴瘤会议上展示。

About large B-cell lymphoma

关于大B细胞淋巴瘤

Large B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL), a blood cancer that originates in the lymphatic system, arising from abnormal B cells, a type of white blood cell responsible for producing antibodies to fight infections.

大B细胞淋巴瘤是一种非霍奇金淋巴瘤（NHL），这是一种起源于淋巴系统的血液癌症，由异常的B细胞产生，这种白细胞负责产生抗体以对抗感染。

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The malignant cells grow rapidly in lymph nodes or other organs and can spread quickly throughout the body.

恶性细胞在淋巴结或其他器官中迅速生长，并可能很快扩散到全身。

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These abnormal cells are larger than normal, healthy B-cells.

这些异常细胞比正常、健康的B细胞更大。

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Diffuse (D) LBCL is the most common and aggressive type where cells are spread out (diffuse) rather than grouped together when they are examined under a microscope.

弥漫性 (D) LBCL 是最常见且最具侵袭性的类型，在显微镜下观察时，细胞是分散的（弥漫性），而不是聚集在一起。

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DLBCL accounts for approximately 40 percent of all NHL cases globally and is estimated to have 150,000 new cases diagnosed each year.

DLBCL约占全球所有NHL病例的40%，据估计每年有150,000例新诊断病例。

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While some patients respond to initial treatment, up to 40 percent can relapse or become refractory to therapy.

一些患者对初始治疗有反应，但多达40%的患者可能会复发或对治疗产生耐药性。

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LBCL and DLBCL patients often face limited treatment options and a poor prognosis, highlighting the urgent need for innovative therapies. Common symptoms include rapidly growing lymph nodes, fever, night sweats, weight loss, and fatigue.

LBCL和DLBCL患者通常面临治疗选择有限且预后较差的问题，突显了对创新疗法的迫切需求。常见症状包括快速生长的淋巴结、发热、夜间盗汗、体重减轻和疲劳。

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About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够构建一个世界，在这个世界中，复杂疾病得以预防、治疗和治愈，治疗方法更加智能且侵入性更小，解决方案也更加个性化。凭借我们在创新药物和医疗技术方面的专业知识，我们有能力在当今整个医疗保健解决方案领域进行创新，以实现明天的突破，并对人类健康产生深远影响。

Learn more at .

了解更多，请访问。

https://www.jnj.com/

https://www.jnj.com/

or at

或在

https://www.innovativemedicine.jnj.com

https://www.innovativemedicine.jnj.com

.

。

Follow us at

关注我们

@JanssenUS

@JanssenUS

and

和

@JNJInnovMed

@JNJInnovMed

. Janssen Research & Development, LLC, Janssen Biotech, Inc., and Janssen Global Services, LLC are Johnson & Johnson companies.

杨森研发有限责任公司、杨森生物科技公司和杨森全球服务有限责任公司均为强生公司旗下企业。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of JNJ-90014496. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events.

本新闻稿包含根据1995年《私人证券诉讼改革法案》定义的“前瞻性声明”，涉及产品开发以及JNJ-90014496的潜在益处和治疗影响。读者应注意不要过分依赖这些前瞻性声明。这些声明是基于对未来事件的当前预期。

If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

如果基本假设被证明不准确，或已知或未知的风险或不确定性成为现实，实际结果可能与强生公司的预期和预测大相径庭。风险和不确定性包括但不限于：产品研发固有的挑战和不确定性，包括临床成功的不确定性和获得监管批准的不确定性；商业成功的不确定性；生产困难和延误；竞争，包括技术进步、竞争对手推出的新产品和获得的专利；专利挑战；因产品功效或安全问题导致的产品召回或监管行动；医疗保健产品和服务购买者的行为和支出模式的变化；适用法律法规的变动，包括全球医疗改革；以及控制医疗成本的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

这些风险、不确定性和其他因素的进一步列表和描述可以在强生公司最近的年度报告 Form 10-K 中找到，包括标题为“关于前瞻性陈述的警示声明”和“项目1A. 风险因素”的部分，以及强生公司随后的季度报告 Form 10-Q 和其他提交给证券交易委员会的文件中。

Copies of these filings are available online at .

这些文件的副本可在线获取。

www.sec.gov

www.sec.gov

,

，

www.jnj.com

www.jnj.com

or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments.

或应Johnson & Johnson的要求。Johnson & Johnson不承担因新信息或未来事件或发展而更新任何前瞻性声明的义务。

Footnotes:

脚注：

*

*

Dr. Krish Patel, Director of Lymphoma Research, Sarah Cannon Research Institute (SCRI), U.S., has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

美国莎拉坎农研究所（SCRI）淋巴瘤研究主任克里希·帕特尔博士曾为强生公司提供咨询、顾问和演讲服务；他没有因任何媒体工作获得报酬。

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Patel K et al. A Global Phase 1b Study Of JNJ-90014496, A CD19/CD20 Bi-Specific Chimeric Antigen Receptor (CAR) T-Cell Therapy, In Patients (Pts) With Relapsed/Refractory (R/R) Large B-Cell Lymphoma (LBCL). 2025 European Hematology Association.

Patel K 等。JNJ-90014496（一种CD19/CD20双特异性嵌合抗原受体（CAR）T细胞疗法）在复发/难治性（R/R）大B细胞淋巴瘤（LBCL）患者中的全球Ib期研究。2025年欧洲血液学协会。

https://library.ehaweb.org/eha/2025/eha2025-congress/4159316/matthew.ku.a.global.phase.1b.study.of.jnj-90014496.a.cd19.cd20.bi-specific.html

https://library.ehaweb.org/eha/2025/eha2025-congress/4159316/matthew.ku.a.global.phase.1b.study.of.jnj-90014496.a.cd19.cd20.bi-specific.html

. Last accessed June 2025.

最后访问时间：2025年6月。

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2

Lymphoma Action. Diffuse Large B-Cell Lymphoma.

淋巴瘤行动。弥漫性大B细胞淋巴瘤。

https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/diffuse-large-b-cell-lymphoma

https://lymphoma-action.org.uk/淋巴瘤类型-非霍奇金淋巴瘤/弥漫性大B细胞淋巴瘤

. Last accessed June 2025.

最后访问时间：2025年6月。

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3

ClinicalTrials.gov. Study of C-CAR039 in relapsed/refractory B-cell non-Hodgkin lymphoma. Identifier NCT05149391.

ClinicalTrials.gov. C-CAR039在复发/难治性B细胞非霍奇金淋巴瘤中的研究。标识符：NCT05149391。

https://clinicaltrials.gov/study/NCT05149391?term=C-CAR039&rank=1

https://clinicaltrials.gov/study/NCT05149391?term=C-CAR039&rank=1

. Accessed June 2025.

访问时间：2025年6月。

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Clinicaltrials.gov

临床试验.gov

. A Phase 1b Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CART-Cell Therapy in Adult Participants With B-Cell Non-Hodgkin Lymphoma. Identifier NCT05421663.

一项针对成年B细胞非霍奇金淋巴瘤患者的自体CD19/CD20双特异性CART细胞疗法JNJ-90014496的Ib期多中心、开放标签研究。标识符：NCT05421663。

https://clinicaltrials.gov/study/NCT05421663

https://clinicaltrials.gov/study/NCT05421663

. Last accessed June 2025.

最后访问时间：2025年6月。

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Berhan A et al. Diffuse large B cell lymphoma (DLBCL): epidemiology, pathophysiology, risk stratification, advancement in diagnostic approaches and prospects: narrative review.

Berhan A 等。弥漫性大B细胞淋巴瘤（DLBCL）：流行病学、病理生理学、风险分层、诊断方法的进展与前景：叙述性综述。

Discov Oncol

发现肿瘤学

. 2025 Feb 15;16:184.

2025年2月15日；16:184。

https://link.springer.com/content/pdf/10.1007/s12672-025-01958-w.pdf.

https://link.springer.com/content/pdf/10.1007/s12672-025-01958-w.pdf

Last accessed June 2025.

最后访问时间：2025年6月。

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García-Sancho AM et al. Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma: New Approved Options.

加西亚-桑乔 AM 等。复发或难治性弥漫性大B细胞淋巴瘤的治疗：新批准的选择。

J Clin Med

临床医学杂志

. 2023 Dec 22;13(1):70.

. 2023年12月22日；13（1）：70。

https://www.mdpi.com/2077-0383/13/1/70.

https://www.mdpi.com/2077-0383/13/1/70.

Last accessed June 2025.

最后访问时间：2025年6月。

Media contact:

媒体联系人：

Oncology Media Relations

肿瘤学媒体关系

Oncology_media_relations@its.jnj.com

肿瘤学科媒体关系@its.jnj.com

Investor contact:

投资者联系人：

Lauren Johnson

劳伦·约翰逊

investor-relations@its.jnj.com

投资者关系@its.jnj.com

U.S. medical inquiries:

美国医学咨询：

+1 800 526-7736

+1 800 526-7736

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查看原始内容以下载多媒体：

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SOURCE Johnson & Johnson

来源：强生公司