Citius Oncology宣布了LYMPHIR™（E7777）在高风险弥漫性大B细胞淋巴瘤患者中进行商业CAR-T疗法前剂量研究的初步1期顶线数据-动脉网

Citius Oncology Announces Preliminary Topline Phase 1 Data from Study of LYMPHIR™ (E7777) Dosing Prior to Commercial CAR‑T Therapy in High‑Risk Diffuse Large B‑Cell Lymphoma

CISION 等信源发布 2026-03-04 22:15

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可切换为仅中文



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Topline data of investigator‑initiated study at the University of Minnesota and City of Hope demonstrates 86% overall response rate (OR), including 57% complete response (CR) and 29% partial response (PR)

明尼苏达大学和希望之城的研究者发起的研究的初步数据显示，总体反应率（OR）为86%，其中完全反应（CR）为57%，部分反应（PR）为29%。

LYMPHIR was well-tolerated with no dose-limiting toxicities observed

LYMPHIR 耐受性良好，未观察到剂量限制性毒性。

CRANFORD, N.J.

新泽西州克兰福德

，

March 4, 2026

2026年3月4日

/PRNewswire/ -- Citius Oncology, Inc. ('Citius Oncology') (Nasdaq:

/PRNewswire/ -- Citius Oncology, Inc.（“Citius Oncology”）（纳斯达克：

CTOR

构造函数

), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ('Citius Pharma') (Nasdaq:

），一家专注于肿瘤学的生物制药公司，也是Citius Pharmaceuticals, Inc.（“Citius Pharma”）（纳斯达克：

CTXR

), today announced positive topline safety and efficacy results from an investigator‑initiated Phase 1 trial evaluating LYMPHIR™ (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR‑T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma (DLBCL).

），今天宣布了一项由研究者发起的 1 期试验的积极顶线安全性和有效性结果，该试验评估了在高风险复发或难治性弥漫性大B细胞淋巴瘤（DLBCL）患者中，在接受商用 CD19 导向的 CAR-T 疗法之前使用 LYMPHIR™（E7777，地尼白介素 diftitox-cxdl）的效果。

The trial was conducted by lead investigator, Dr. Veronika Bachanova, at the University of Minnesota and City of Hope. Full results were presented at the 2026 ASTCT.

该试验由明尼苏达大学和希望之城的首席研究员维罗尼卡·巴赫anova博士进行。完整结果在2026年ASTCT上公布。

& CIBMTR

Tandem Meetings

串联会议

。

The Phase 1 trial was designed to augment the lymphodepletion regimen prior to CAR‑T infusion through the administration of LYMPHIR to potentially improve the anti‑tumor activity of CAR‑T therapies. LYMPHIR, an engineered fusion toxin that preferentially binds to the IL‑2 receptor expressed on regulatory T-cells (Tregs), is currently FDA-approved and commercially available for the treatment of relapsed or refractory cutaneous T-cell lymphoma (CTCL) after one prior systemic therapy.

第一阶段试验旨在通过给予LYMPHIR来增强CAR-T输注前的淋巴清除方案，以潜在提高CAR-T疗法的抗肿瘤活性。LYMPHIR是一种工程化融合毒素，优先结合在调节性T细胞（Tregs）上表达的IL-2受体，目前已获FDA批准并商业化，用于治疗经过一次先前系统治疗后复发或难治性皮肤T细胞淋巴瘤（CTCL）。

。

'Enhancing Treg depletion prior to CAR‑T infusion with LYMPHIR represents a promising immunomodulatory strategy in patients with high‑risk DLBCL, and these Phase 1 data provide an encouraging signal of the potential to enhance current CAR‑T regimens,' said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma.

“在CAR-T输注前使用LYMPHIR增强Treg耗竭是一种有前景的免疫调节策略，适用于高危DLBCL患者，这些1期数据为增强现有CAR-T方案的潜力提供了令人鼓舞的信号，”Citius Oncology和Citius Pharma执行副总裁兼首席医学官Myron Czuczman博士表示。

'These positive data support our broader strategy of exploring LYMPHIR's modulatory effect on Tregs in combination with other approved therapies to potentially enhance the body's own immune system to fight cancerous tumors,' he added..

“这些积极的数据支持了我们更广泛的战略，即探索LYMPHIR与其它已批准疗法联合使用时对Tregs的调节作用，以潜在增强人体自身免疫系统对抗癌性肿瘤的能力，”他补充道。

Topline Results & Study Design

顶线结果与研究设计

All patients (n=14) completed treatment and proceeded to CAR-T infusion;

所有患者（n=14）均完成治疗并进行CAR-T输注；

LYMPHIR was well tolerated, with no dose-limiting toxicities observed;

LYMPHIR 耐受性良好，未观察到剂量限制性毒性；

No Grade ≥3 LYMPHIR-related immune adverse events or infusion reactions were reported; and,

未报告任何3级或以上与LYMPHIR相关的免疫不良事件或输液反应；并且，

Data demonstrated effective Treg depletion, and promising efficacy signals of enhanced standard lymphodepletion with the use of Treg-targeting LYMPHIR.

数据显示，有效地耗尽了调节性T细胞（Treg），并且使用靶向Treg的LYMPHIR增强了标准淋巴细胞清除的效果，展现了良好的疗效信号。

The Phase 1, open-label, dose-escalation study (

第1阶段，开放标签，剂量递增研究 (

NCT04855253

), enrolled 14 patients with relapsed or refractory DLBCL exhibiting poor prognostic features, including double/triple hit genetics, primary refractory disease, and extranodal involvement. Participants received one dose of LYMPHIR (E7777) at 5, 7, or 9 µg/kg followed by low dose chemotherapy prior to standard commercial CD19-directed CAR-T cell therapy.

），入组了14名具有不良预后特征的复发或难治性DLBCL患者，这些特征包括双重/三重打击遗传学、原发难治性疾病以及结外受累。参与者在标准商业CD19导向的CAR-T细胞疗法之前，接受了5、7或9 µg/kg剂量的LYMPHIR（E7777）以及低剂量化疗。

All patients received an infusion of one of the following FDA‑approved, commercially manufactured CAR‑T products: axicabtagene ciloleucel (Yescarta.

所有患者均接受了以下 FDA 批准的商业生产的 CAR-T 产品之一的输注：axicabtagene ciloleucel（Yescarta）。

; Kite Pharma/Gilead Sciences), lisocabtagene maraleucel (Breyanzi

；Kite Pharma/Gilead Sciences），lisocabtagene maraleucel（Breyanzi）

; Bristol Myers Squibb), or tisagenlecleucel (Kymriah

；百时美施贵宝），或替沙基勒细胞（Kymriah）

; Novartis).

；诺华公司）。

The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.

本研究中使用 LYMPHIR 属于研究性质，超出了其 FDA 批准的适应症范围。第一阶段研究并未设计或具备评估临床疗效的能力，因此无法就比较效果或长期结果得出任何结论。

Key Findings from the Phase 1 Trial

第一阶段试验的主要发现

Overall response rate (ORR) was 86% at one month, including 57% complete responses (CR) and 29% partial responses (PR);

总体缓解率（ORR）在一个月时为86%，其中包括57%的完全缓解（CR）和29%的部分缓解（PR）；

One‑year progression‑free survival (PFS) was 77% (95% CI: 43–92%);

一年无进展生存率（PFS）为77%（95%置信区间：43-92%）；

One‑year overall survival (OS) was 84% (95% CI: 49–96%);

一年总生存率（OS）为84%（95%置信区间：49%-96%）；

A single LYMPHIR dose resulted in depletion of circulating Tregs in all but one patient;

单一剂量的LYMPHIR导致了除一名患者外所有患者循环Tregs的耗竭；

Median reduction of 24 Tregs/µL (range 8–65);

中位数减少24 Tregs/µL（范围8-65）；

Treg nadir was observed 24 hours post‑LYMPHIR;

Treg最低点在LYMPHIR后24小时观察到；

LYMPHIR was well tolerated with no dose‑limiting toxicities (DLTs) observed up to 9 µg/kg; and,

LYMPHIR 耐受性良好，在高达 9 µg/kg 的剂量下未观察到剂量限制性毒性 (DLTs)；并且，

Reported adverse events included manageable Grade 1–2 capillary leak syndrome, fever, and transient liver enzyme elevations; Grade 3 cytopenias were consistent with expected lymphodepletion. CAR-T related cytokine release syndrome (CRS) occurred in 43% of patients (all Grade 1/2), and immune effector cell‑associated neurotoxicity syndrome (ICANS) occurred in 21% (primarily low grade)..

报告的不良事件包括可管理的1-2级毛细血管渗漏综合征、发热和短暂的肝酶升高；3级细胞减少症与预期的淋巴细胞清除作用一致。43%的患者出现CAR-T相关的细胞因子释放综合征（CRS）（均为1/2级），21%的患者出现免疫效应细胞相关神经毒性综合征（ICANS）（主要为低级别）。

'In this high-risk population, LYMPHIR showed a favorable safety profile and promising pharmacodynamic effects when administered prior to CAR-T therapies. This data sets the stage for a larger study to assess its potential to enhance CAR-T efficacy through longer duration of LYMPHIR use,' said Dr. Veronika Bachanova, Principal Investigator and Professor of Medicine at the University of Minnesota..

“在这个高风险人群中，LYMPHIR 在 CAR-T 疗法之前使用时显示出良好的安全性及令人鼓舞的药效学效果。这些数据为开展更大规模的研究奠定了基础，以评估通过延长 LYMPHIR 使用时间来增强 CAR-T 疗效的潜力，”明尼苏达大学医学教授兼首席研究员 Veronika Bachanova 博士表示。

Dr. Bachanova presented the topline data at the 2026 Tandem Meetings | ASTCT

巴赫诺娃博士在2026年Tandem会议 | ASTCT上展示了初步数据。

CIBMTR

。

Title

标题

: E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T for High-Risk LBCL

：E7777 用于在 CAR-T 治疗高危 LBCL 前增强调节性 T 细胞耗竭

Presentation ID

幻灯片 ID

: 677608

Abstract ID

摘要 ID

: 296369

About Diffuse Large B-Cell Lymphoma (DLBCL)

关于弥漫性大B细胞淋巴瘤（DLBCL）

Diffuse large B-cell lymphoma (DLBCL) is the most common subtype of non-Hodgkin lymphoma (NHL), accounting for approximately 30%–40% of newly diagnosed cases in the United States. DLBCL is an aggressive and rapidly growing cancer of B lymphocytes, a type of white blood cell responsible for producing antibodies.

弥漫性大B细胞淋巴瘤 (DLBCL) 是非霍奇金淋巴瘤 (NHL) 中最常见的亚型，在美国约占新诊断病例的30%-40%。DLBCL是一种侵袭性强、生长迅速的B淋巴细胞癌，B淋巴细胞是一种负责产生抗体的白细胞。

While frontline chemoimmunotherapy regimens such as R-CHOP can be curative for many patients, up to 40% experience relapse or refractory disease. High-risk features are associated with poor outcomes and limited responses to standard therapies, including CAR-T cell therapy. Novel strategies that modulate the tumor microenvironment, such as transient regulatory T-cell depletion, are under investigation to improve treatment efficacy and long-term remission rates in this difficult-to-treat population..

虽然前线化疗免疫疗法方案（如R-CHOP）可以治愈许多患者，但多达40%的患者会经历复发或难治性疾病。高风险特征与不良预后及对标准治疗（包括CAR-T细胞疗法）的有限反应相关。目前，一些新颖的策略正在研究中，这些策略通过调节肿瘤微环境（例如短暂耗竭调节性T细胞）来提高治疗效果和长期缓解率，以改善这一难治人群的预后。

About LYMPHIR™ (denileukin diftitox‑cxdl)

关于LYMPHIR™（地尼白介素 diftitox‑cxdl）

LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments.

LYMPHIR 是一种用于治疗复发或难治性皮肤T细胞淋巴瘤（CTCL）的靶向免疫疗法，适用于在至少一种先前系统治疗后的I-III期疾病。它是一种重组融合蛋白，结合了IL-2受体结合域和白喉毒素（DT）片段。

The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors..

该药剂特异性结合到细胞表面的IL-2受体上，使进入细胞的白喉毒素片段抑制蛋白质合成。被细胞摄取后，DT片段被切割，游离的DT片段抑制蛋白质合成，导致细胞死亡。Denileukin diftitox-cxdl显示出通过直接杀伤作用清除免疫抑制性调节性T淋巴细胞（Tregs）以及对表达IL-2R的肿瘤发挥抗肿瘤活性的能力。

In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia.

2021年，denileukin diftitox在日本获得监管批准，用于治疗复发或难治性CTCL和外周T细胞淋巴瘤（PTCL）。随后，在2021年，Citius获得了独家许可，拥有除印度、日本和亚洲某些地区以外所有市场开发和商业化denileukin diftitox的权利。

LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025..

LYMPHIR（地尼白介素 diftitox-cxdl）于2025年12月获得FDA批准，并随后在美国上市。

About Citius Oncology, Inc.

关于Citius Oncology公司

Citius Oncology, Inc. (Nasdaq:

Citius Oncology, Inc.（纳斯达克：

CTOR

构造函数

) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies.

）是一个开发和商业化新型靶向肿瘤治疗的平台。2025年12月，Citius Oncology推出了LYMPHIR，该药物获FDA批准用于治疗曾接受过至少一种先前系统治疗的复发或难治性I–III期CTCL成年患者。管理层估计，LYMPHIR的初始市场目前超过4亿美元，且正在增长，现有疗法尚未充分满足需求。

Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit .

强大的知识产权保护涵盖孤儿药资格、复杂技术、商业秘密以及用于免疫肿瘤学与检查点抑制剂联用的待批专利，这将进一步巩固Citius Oncology的竞争地位。欲了解更多信息，请访问。

www.citiusonc.com

。

Forward-Looking Statements

前瞻性声明

This press release may contain 'forward-looking statements' within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as 'will,' 'anticipate,' 'estimate,' 'expect,' 'plan,' 'should,' and 'may' and other words and terms of similar meaning or use of future dates.

本新闻稿可能包含1933年《证券法》第27A条和1934年《证券交易法》第21E条所指的“前瞻性陈述”。此类陈述是基于我们对影响Citius Oncology未来事件的预期和信念作出的。您可以通过它们使用的词汇来识别这些陈述，例如“将”、“预期”、“估计”、“预计”、“计划”、“应该”、“可能”以及其他类似含义的词汇或使用未来日期的表述。

Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; early-stage clinical data may not be predictive of results from larger or later-stage studies;, our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributor.

前瞻性声明基于管理层的当前预期，并受可能对我们的业务、经营结果、财务状况和股价产生负面影响的风险和不确定性因素制约。可能导致实际结果与当前预期存在重大差异的因素包括：与研发活动结果相关的风险，包括来自我们现有资产和任何新管线资产的风险；早期临床数据可能无法预测更大规模或后期研究的结果；我们对大量额外资金的需求以及我们为至少未来12个月的运营筹集额外资金以维持持续经营的能力；我们成功将LYMPHIR商业化并建立可持续收入流的能力；LYMPHIR及我们的候选产品市场的预估规模及其在任何市场中的接受程度；我们获取战略合作伙伴关系并扩大LYMPHIR国际准入的能力；我们维持纳斯达克持续上市标准的能力；我们利用最新技术来支持LYMPHIR商业化工作的能力；医生和患者在竞争激烈的治疗环境中对LYMPHIR的接受度；我们对第三方物流供应商和分销商的依赖。

www.sec.gov

, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law..

，包括Citius Oncology截至2025年9月30日的年度报告Form 10-K，该报告已于2025年12月23日提交给美国证券交易委员会（SEC）。这些前瞻性声明仅截至本文发布之日有效，我们明确声明不承担任何义务或承诺公开发布对本文包含的任何前瞻性声明的更新或修订，以反映我们预期的任何变化或任何相关事件、条件或情况的变化，除非法律另有要求。

REFERENCES:

参考文献：

Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT

串联会议：美国移植与细胞治疗学会（ASTCT）的移植与细胞治疗会议

) & the Center for International Blood and Marrow Transplant Research (CIBMTR

）和国际血液与骨髓移植研究中心（CIBMTR）

)

Yescarta® is a registered trademark of Kite Pharma, Inc., a Gilead company.

Yescarta® 是 Kite Pharma, Inc.（吉利德旗下公司）的注册商标。

Breyanzi® is a registered trademark of Bristol Myers Squibb.

Breyanzi® 是百时美施贵宝的注册商标。

Kymriah® is a registered trademark of Novartis.

Kymriah® 是诺华的注册商标。

LYMPHIR™ (denileukin diftitox‑cxdl)

LYMPHIR™（地尼白介素二氧杂环丁烷‑cxdl）

INDICATION

适应症

LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

LYMPHIR是一种IL2受体导向的细胞毒素，适用于治疗至少经过一次先前系统治疗后复发或难治性I-III期皮肤T细胞淋巴瘤（CTCL）的成年患者。

IMPORTANT SAFETY INFORMATION

重要安全信息

BOXED WARNING: CAPILLARY LEAK SYNDROME

黑框警告：毛细血管渗漏综合征

Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.

毛细血管渗漏综合征 (CLS)，包括危及生命或致命的反应，可能发生在接受LYMPHIR治疗的患者中。在治疗期间监测患者是否出现CLS的体征和症状。根据严重程度，暂停LYMPHIR直至CLS缓解，或永久停用。

WARNINGS AND PRECAUTIONS

警告和注意事项

Capillary Leak Syndrome

毛细血管渗漏综合征

LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome..

LYMPHIR可能引起毛细血管渗漏综合征（CLS），包括危及生命或致命的反应。在临床试验中，CLS被定义为在LYMPHIR治疗期间任何时候出现以下至少两种症状：低血压、水肿和血清白蛋白<3 g/dL。这些症状不需要同时发生即可被归类为毛细血管渗漏综合征。

As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution.

根据定义，在三项临床试验的汇总人群中，27%的患者发生了CLS（毛细血管渗漏综合征），其中8%为3级。有一例（0.8%）CLS致死事件。在发生CLS的患者中，22%出现复发。大多数CLS事件（81%）发生在治疗的前两个周期内。从第1周期第1天起，CLS发生的中位时间为6.5天（范围：1至77天），CLS的中位持续时间为14天（范围：2至40天），且75%的患者症状得到缓解。

The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred..

最常见的症状包括水肿、低白蛋白血症和低血压。还出现了胸腔积液、心包积液和脱水。

Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.

定期评估患者体重增加、水肿新发或加重、呼吸困难和低血压（包括体位性变化）的情况。在每个治疗周期开始前监测血清白蛋白水平，并根据临床需要更频繁地进行监测。

Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

根据严重程度，暂停、减少剂量或永久停用。如果暂停使用LYMPHIR，则在CLS消退且血清白蛋白大于或等于3 g/dL时恢复使用LYMPHIR。

Visual Impairment

视力障碍

LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment..

LYMPHIR可能导致严重的视力损害，包括视力和色觉的变化。在3项临床试验的汇总人群中，9%的患者出现视力损害，其中8%为1级，1%为2级。最常报告的症状是视力模糊。在出现视力损害的患者中，67%的患者视力损害得到解决。

Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.

进行基线眼科检查并根据临床需要进行监测。如果患者出现视力受损的症状，如视力清晰度变化、色觉变化或视力模糊，应转诊进行眼科评估。

Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.

直到视力障碍缓解或根据严重程度永久停用LYMPHIR。

Infusion-Related Reactions

输液相关反应

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4%. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2.

LYMPHIR可能引起严重的输液相关反应。在三项临床试验的汇总人群中，接受LYMPHIR治疗的患者中有69%报告了输液相关反应，其中3.4%为3级输液相关反应。83%的输液相关反应发生在第1和第2周期。

The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia..

最常见的症状包括恶心、疲劳、寒战、肌肉骨骼疼痛、呕吐、发烧和关节痛。

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

在开始LYMPHIR输注前，对患者进行前三次周期的预用药。在输注期间频繁监测患者。对于2级或更高级别的输注反应，在每次后续输注前至少30分钟使用全身性类固醇进行预处理，持续至少3个周期。

Interrupt or discontinue LYMPHIR based on severity. Institute appropriate medical management.

根据严重程度中断或停止使用LYMPHIR。实施适当的医疗管理。

Hepatotoxicity

肝毒性

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved.

LYMPHIR 可能导致肝毒性。在汇总的安全性人群中，70% 的患者出现 ALT 升高，其中 22% 为 3 级 ALT 升高；64% 的患者出现 AST 升高，其中 9% 为 3 级 AST 升高。对于 3 级事件，中位发病时间为 8 天（范围：1 至 15 天）；中位缓解时间为 15 天（范围：7 至 50 天）；所有 3 级 ALT 或 AST 升高的病例均得到解决。

Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%..

总胆红素升高发生在5%的患者中，其中3级升高的发生率为0.9%。

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

在基线和治疗期间根据临床需要监测肝酶和胆红素。根据严重程度，暂停、减少剂量或永久停用LYMPHIR。

Embryo-Fetal Toxicity

胚胎-胎儿毒性

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR..

基于其作用机制，LYMPHIR 在给孕妇使用时可能会对胎儿造成伤害。在开始使用 LYMPHIR 之前，应确认育龄女性的怀孕状态。告知孕妇对胎儿存在的潜在风险。建议育龄女性在治疗期间以及使用 LYMPHIR 最后一剂后的 7 天内使用有效避孕措施。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

最常见的不良反应（≥20%），包括实验室异常，是转氨酶升高、白蛋白减少、恶心、水肿、血红蛋白减少、疲劳、肌肉骨骼疼痛、皮疹、寒战、便秘、发热和毛细血管渗漏综合征。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy

怀孕

Risk Summary

风险概述

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox..

基于其作用机制，LYMPHIR 在给予孕妇时可能会对胎儿造成伤害。目前尚无关于在孕妇中使用 LYMPHIR 的数据以评估与药物相关的风险。尚未进行使用地尼鲁金毒素的动物生殖和发育毒性研究。

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

地尼白介素 diftitox-cxdl 会导致调节性 T 淋巴细胞 (Treg) 耗竭、免疫激活和毛细血管渗漏综合征，影响妊娠的维持。请告知孕妇对胎儿的潜在风险。

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

在美国普通人群中，临床确认妊娠中重大出生缺陷和流产的估计背景风险分别为2-4%和15-20%。

Lactation

泌乳

Risk Summary

风险概述

No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose..

目前尚无关于denileukin diftitox-cxdl是否存在于人乳、对哺乳婴儿的影响或对乳汁分泌的影响的数据。由于哺乳婴儿可能出现严重不良反应，建议女性在使用LYMPHIR治疗期间及最后一剂后的7天内不要哺乳。

Females and Males of Reproductive Potential

生育年龄的女性和男性

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

基于其作用机制，LYMPHIR 在给孕妇使用时可能会对胎儿造成伤害。

Pregnancy Testing

妊娠试验

Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

在开始使用LYMPHIR之前，应确认具有生殖潜力的女性的怀孕状态。

Contraception

避孕措施

Females

女性

Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

建议有生育潜力的女性在使用LYMPHIR治疗期间及最后一剂后的7天内使用有效避孕措施。

Infertility

不孕不育

Males

男性

Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

基于在大鼠中的研究发现，LYMPHIR 治疗可能会损害男性生育能力。其对生育能力影响的可逆性尚不清楚。

Pediatric Use

儿科使用

Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

LYMPHIR在儿科患者中的安全性和有效性尚未确定。

Geriatric Use

老年使用

Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. .

在69名接受LYMPHIR治疗的I-III期r/r CTCL患者中，34名患者（49%）年龄在65岁及以上，10名患者（14%）年龄在75岁及以上。LYMPHIR的临床研究未包括足够数量的65岁及以上的患者，因此无法确定他们是否与较年轻的成年患者反应不同。

You may report side effects to the FDA at 1-800-FDA-1088 or

您可以拨打1-800-FDA-1088向FDA报告副作用，或者

www.fda.gov/medwatch

. You may also report side effects to Citius Oncology at 1-844-459-6744.

您也可以通过1-844-459-6744向Citius Oncology报告副作用。

Please read Important Safety Information and

请阅读重要的安全信息和

full Prescribing Information

完整处方信息

, including Boxed WARNING, for LYMPHIR.

，包括盒装警告，适用于LYMPHIR。