Mivocabtagene Autoleucel(Kyverna)(Mivocabtagene Autoleucel(Kyverna)) - 药物靶点：CD19 x CD28_在研适应症：僵人综合征，重症肌无力，坐骨跖骨发育不良_专利_临床

概要

基本信息

药物类型

自体CAR-T

别名

Autologous anti-CD19 CAR T cell immunotherapy transduced with lentiviral vector (Kyverna)、Miv-Cel、KYV 101

+ [2]

靶点

CD19 x CD28

作用方式

抑制剂、激动剂

作用机制

CD19抑制剂(B淋巴细胞抗原CD19抑制剂)、CD28激动剂(T细胞特异性表面糖蛋白CD28激动剂)、T淋巴细胞替代物

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [5]

在研适应症

僵人综合征重症肌无力坐骨跖骨发育不良+ [10]

非在研适应症-

原研机构

Kyverna Therapeutics, Inc.

在研机构

Kyverna Therapeutics, Inc.

Hannover Medical School

德昇济医药（无锡）有限公司

非在研机构-

权益机构

Verily Life Sciences LLC

Kyverna Therapeutics, Inc.

National Institutes of Health

最高研发阶段申请上市

首次获批日期-

最高研发阶段(中国)-

特殊审评孤儿药 (美国)、再生医学先进疗法 (美国)、快速通道 (美国)

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关联

13

项与 Mivocabtagene Autoleucel(Kyverna) 相关的临床试验

NCT07403188

/ RecruitingN/A

A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101

The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).
This LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).

开始日期2025-11-24

申办/合作机构

Kyverna Therapeutics, Inc.

NCT06590545

/ Not yet recruiting临床1/2期IIT

Anti-CD 19 CAR-T Cell Therapy in Patients with ANCA Vasculitis: a Two-stage Interventional, Prospective, Open-label, Phase I/II Trial in Patients with Active, Treatment Refractory, ANCA-IgG-positive Vasculitis

The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA associated vasculitis (AAV).
The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory, ANCA-IgG-positive AAV
* To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory ANCA-IgG-positive AAV
* To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV
Participants will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR-T cell immunotherapy. Follow-up time is 52 weeks with regular visits at the site.

开始日期2025-01-01

申办/合作机构

Kyverna Therapeutics, Inc.

NCT06475495

/ Active, not recruiting临床1/2期IIT

Comparison of B-cell Depletion by Rituximab and Anti-CD 19 CAR-T Therapy in Patients With Rheumatoid Arthritis. Two-stage Interventional, Prospective, Randomized, Controlled, Open Label, Parallel-group Phase I/II Trial in Patients With Active, ACPA-positive and Treatment Refractory Rheumatoid Arthritis

The goal of this phase I/II clinical trial is to compare B-cell depletion by rituximab and anti-CD 19 CAR-T therapy in patients with rheumatoid arthritis. The main questions it aims to answer are:
* To assess the safety of anti-CD19 CAR T cell therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-I)
* To assess the safety of anti-CD19 CAR T cell therapy and of rituximab in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
* To assess ACPA seroconversion after anti-CD19 CAR T cell or rituximab therapy in subjects with active, ACPA positive and treatment refractory RA (Phase-II)
Participants in the test-arm will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR T-cell immunotherapy. In the comparator group patients will receive 2x1 g Rituximab i.v.
Follow-up time (both arms) is 52 weeks with regular visits at the site.

开始日期2024-12-04

申办/合作机构

Kyverna Therapeutics, Inc.

100 项与 Mivocabtagene Autoleucel(Kyverna) 相关的临床结果

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100 项与 Mivocabtagene Autoleucel(Kyverna) 相关的转化医学

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100 项与 Mivocabtagene Autoleucel(Kyverna) 相关的专利（医药）

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5

项与 Mivocabtagene Autoleucel(Kyverna) 相关的文献（医药）

2025-11-01·Neurology-Neuroimmunology & Neuroinflammation

Anti-CD19 CAR T-Cell Therapy in Advanced Stiff-Person Syndrome and Concomitant Myasthenia Gravis

Article

作者: Motte, Jeremias ; Borie, Dominic ; Lohmann, Clarissa ; Aloizou, Athina-Maria ; Schroers, Roland ; Mika, Thomas ; Schneider-Gold, Christiane ; Faissner, Simon ; Gold, Ralf ; Ayzenberg, Ilya

BACKGROUND:

Autologous chimeric antigen receptor (CAR) T-cell therapy has recently gained interest in the treatment of rheumatic and neuroimmunologic diseases.

METHODS:

We report a 62-year-old female patient with a 14-year history of treatment-refractory anti-GAD-positive stiff-person syndrome (SPS) and concomitant anti-AChR-positive myasthenia gravis. Despite a relatively stable disease course in the first 8 years, SPS dramatically progressed afterward. In 2023, she was able to walk less than 10-15 m and suffered from severe persistent stiffness in the left arm superimposed with painful muscle spasm attacks (MSAs). Numerous immunotherapies, including intravenous immunoglobulins, plasma exchange, steroids, azathioprine, and rituximab, were ineffective. Consequently, she was escalated to compassionate use of autologous anti-CD19 CAR T-cell therapy (KYV-101).

RESULTS:

From the third month post-CAR-T, we observed a substantial improvement in walking distance, pain, anxiety, and MSAs in the arm. By the sixth month, she was able to walk 500 m. The anti-GAD titers declined from 1:320 to 1:32. Side effects included grade 2 cytokine release syndrome and moderate leukopenia, without serious infections.

DISCUSSION:

CAR T-cell therapy was effective at mitigating SPS symptoms, despite the long history and severe refractory disease course in our patient. Controlled trials are needed to evaluate its potential in SPS.

2025-07-01·Med

Chimeric antigen receptor T cells in treatment-refractory DAGLA antibody-associated encephalitis

Article

作者: Mougiakakos, Dimitrios ; Haghikia, Aiden ; Schett, Georg ; Gold, Ralf ; Motte, Jeremias ; Pappa, Vaia ; Wickel, Jonathan ; Neyazi, Alexandra ; Faissner, Simon ; Wolleschak, Denise ; Duscha, Alexander ; Böttcher, Martin ; Borie, Dominic ; Geis, Christian ; Hegelmaier, Tobias ; Miske, Ramona ; Desel, Christiane

BACKGROUND:

Autoimmune encephalitides are a heterogeneous group of autoantibody-associated central nervous system disorders. The clinical course of autoimmune encephalitides can be life threatening, and treatment can be challenging.

OBJECTIVE:

This report describes a case of treatment-refractory, anti-diacylglycerol lipase alpha (DAGLA) antibody-associated autoimmune encephalitis successfully treated with chimeric antigen receptor (CAR) T cells.

METHODS:

Treatment was done by single intravenous infusion of fully human, second-generation CAR T cells (KYV-101) targeting CD19 and depleting B cells. Clinical response was measured by International Cooperative Ataxia Rating Scale and Clinical Assessment Scale in Autoimmune Encephalitis scores. Autoantibodies against DAGLA were measured by a recombinant cell-based indirect immunofluorescence assay in the serum and the cerebrospinal fluid and confirmed by staining of primary murine neurons and brain sections.

FINDINGS:

A 36-year-old man developed rapidly progressing generalized myoclonus, cerebellar head tremor, vertical binocular nystagmus, and tetraparesis despite treatment with pulse glucocorticoid therapy, plasma exchange, and rituximab. Anti-DAGLA antibodies were positive in the indirect immunofluorescence assay, in serum and cerebrospinal fluid, and reacted with neurons and brain sections. Due to his severe clinical condition and treatment refractoriness, the patient received a single infusion of autologous anti-CD19 CAR T cells. Clinical scores improved significantly after treatment, and anti-DAGLA antibody levels in serum and cerebrospinal fluid diminished. Oligoclonal bands in the cerebrospinal fluid were initially positive and became negative after CAR T cell therapy.

CONCLUSION:

The report highlights the therapeutic potential of anti-CD19 CAR T cell therapy in severe, treatment-refractory autoimmune encephalitis.

FUNDING:

There was no external funding for the treatment or the data generated.

2024-06-01·Med (New York, N.Y.)

CD19-targeted chimeric antigen receptor T cell therapy in two patients with multiple sclerosis

Article

作者: Kuhle, Jens ; Berger, Susanna Carolina ; Rathje, Kristin ; Fischbach, Felix ; Fehse, Boris ; Seibel, Johan ; Badbaran, Anita ; Friese, Manuel A ; Pfeffer, Lena Kristina ; Ayuk, Francis ; Richter, Johanna ; Heesen, Christoph ; Kröger, Nicolaus ; Borie, Dominic ; Reinhardt, Stefanie ; Gagelmann, Nico

BACKGROUND:

Progressive multiple sclerosis (MS) is characterized by compartmentalized smoldering neuroinflammation caused by the proliferation of immune cells residing in the central nervous system (CNS), including B cells. Although inflammatory activity can be prevented by immunomodulatory therapies during early disease, such therapies typically fail to halt disease progression. CD19 chimeric antigen receptor (CAR)-T cell therapies have revolutionized the field of hematologic malignancies. Although generally considered efficacious, serious adverse events associated with CAR-T cell therapies such as immune effector cell-associated neurotoxicity syndrome (ICANS) have been observed. Successful use of CD19 CAR-T cells in rheumatic diseases like systemic lupus erythematosus and neuroimmunological diseases like myasthenia gravis have recently been observed, suggesting possible application in other autoimmune diseases.

METHODS:

Here, we report the first individual treatment with a fully human CD19 CAR-T cell therapy (KYV-101) in two patients with progressive MS.

FINDINGS:

CD19 CAR-T cell administration resulted in acceptable safety profiles for both patients. No ICANS was observed despite detection of CD19 CAR-T cells in the cerebrospinal fluid. In case 1, intrathecal antibody production in the cerebrospinal fluid decreased notably after CAR-T cell infusion and was sustained through day 64.

CONCLUSIONS:

CD19 CAR-T cell administration in progressive MS resulted in an acceptable safety profile. CAR-T cell presence and expansion were observed in the cerebrospinal fluid without clinical signs of neurotoxicity, which, along with intrathecal antibody reduction, indicates expansion-dependent effects of CAR-T cells on CD19⁺ target cells in the CNS. Larger clinical studies assessing CD19 CAR-T cells in MS are warranted.

FUNDING:

Both individual treatments as well the generated data were not based on external funding.

276

项与 Mivocabtagene Autoleucel(Kyverna) 相关的新闻（医药）

22 小时之前

·GlobeNewswire-Health Care

Kyverna Therapeutics to Present at Upcoming Investor Conferences

EMERYVILLE, Calif., May 14, 2026 (GLOBE NEWSWIRE) -- Kyverna Therapeutics, Inc. (Nasdaq: KYTX), a late-stage clinical biopharmaceutical company focused on developing cell therapies for patients with autoimmune diseases, today announced that company management will present at the following upcoming conferences: H.C. Wainwright 4th Annual Nasdaq BioConnect Conference Format: Fireside chat and investor meetingsDate: Tuesday, May 19th, 2026Time: 2:30 p.m. ET Jefferies Global Healthcare Conference Format: Corporate presentation and investor meetingsDate: Wednesday, June 3rd, 2026Time: 3:10 p.m. ET Live webcasts of the presentations may be accessed via the Investors section of the Kyverna website at ir.kyvernatx.com. Replays of the webcasts will be available on the website for 90 days following the conference. About Kyverna Therapeutics Kyverna Therapeutics, Inc. (Nasdaq: KYTX) is a late-stage clinical biopharmaceutical company focused on liberating autoimmune patients through the curative potential of cell therapy. Kyverna’s lead autologous CD19-targeting CAR T-cell therapy candidate, miv-cel (mivocabtagene autoleucel, KYV-101), has demonstrated the potential to fundamentally change the treatment paradigm across multiple B-cell-driven autoimmune diseases. Kyverna is advancing its potentially first-in-class neuroimmunology franchise with its recently completed registrational trial in stiff person syndrome and an ongoing registrational trial for generalized myasthenia gravis. The Company is also harnessing other KYSA trials and investigator-initiated trials, including in multiple sclerosis and rheumatoid arthritis, to inform the next priority indications. Additionally, its next generation pipeline includes CAR T-cell therapies deploying novel innovations to improve patient access and experience. For more information, please visit https://kyvernatx.com. Contact: Investors: InvestorRelations@kyvernatx.com Media: media@kyvernatx.com

细胞疗法免疫疗法临床研究

2026-05-14

·研发客

单臂的胜利？全球首款自免CAR-T启动上市申请

近日，Kyverna Therapeutics宣布已与美国FDA完成僵人综合征（SPS）候选CAR-T疗法miv‑cel的生物制品上市申请（BLA）预审沟通并达成监管共识，正式启动滚动式上市申报工作。来源|Kyverna官网据新闻稿披露的预审会议沟通共识，FDA认可其关键Ⅱ期 KYSA‑8单臂临床试验数据足以支撑上市申请，明确16周时25英尺定时行走测试（T2FW）为主要疗效终点，同时敲定临床安全性、临床前研究、CMC等全套申报资料要求。Kyverna计划依托再生医学先进疗法（RMAT）资格申请优先审评，预计2026年第四季度完成全部BLA递交。 miv‑cel一定程度上消除了单臂研究的监管不确定性。此前，FDA因uniQure公司亨廷顿病基因疗法仅采用单臂试验对比自然病史数据的设计，而对其项目提出了质疑。僵人综合征目前尚无获批的特效药，该病会引发全身肌肉僵硬、痉挛剧痛，行动受限且身心备受煎熬，加拿大传奇歌星Céline Dion曾在2022年底公开确认罹患僵人综合征（SPS）。 KYSA‑8 关键性临床试验主要分析数据显示，单次输注 miv‑cel 即可显著逆转患者残疾评分，16周时所有主要及次要终点均实现统计学显著且持久的临床获益；截至16周及最后一次随访，所有患者无需继续接受免疫治疗，且疗法整体耐受性良好。 Kyverna将于2026年下半年公布KYSA‑8试验1年随访数据。值得关注的是，德国通过同情用药渠道接受miv‑cel治疗的两名僵人综合征患者，已分别实现超15个月和26个月的持续疗效，无需长期免疫治疗。在2026年美国AAN年会上，Kyverna同步公布一项大型多中心回顾性自然病史研究结果。该研究纳入153名接受超说明书免疫治疗或对症用药的僵人综合征患者，结果显示多数患者行走能力改善有限甚至无改善，且随病程进展愈发依赖助行工具，印证现有治疗手段疗效不足，凸显miv‑ce的突破性临床价值，同时佐证T25FW可作为评估僵直人综合征患者活动能力的有效长期指标。除僵人综合征外，Kyverna针对全身型重症肌无力（gMG）的Ⅲ期临床试验患者入组持续推进，其Ⅱ期试验1年长期随访数据已证实疗法具备持久疗效。Miv-cel 针对进行性多发性硬化症 (PMS) 的IIT研究中也取得了初步的积极数据。商业化布局方面，Kyverna表示其目前的生产能力可以支持miv-cel的上市。Kyverna还任命Nadia Dac担任首席商务官，全面推进miv‑cel商业化筹备，计划 2027年实现产品上市。 Kyverna首席执行官Warner Biddle表示：“作为首家为自免CAR‑T疗法递交BLA的企业，通过单臂临床试验获得FDA监管认可，为miv‑cel打通上市路径，不仅是Kyverna的重要里程碑，也对整个行业意义深远。这一成果印证了miv‑cel 的巨大潜力，僵人综合征是我们的首个突破方向。随着滚动上市申请推进及商业化筹备落地，我们正打造覆盖多种神经免疫疾病的CAR‑T疗法管线，继续巩固自免CAR‑T领域的领先地位。” 总第2900期访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

2026-05-14

·生物科技馆

全球首款自免 CAR-T 递交滚动 BLA，预计明年商业化！多款进入 III 期，将迎来新爆发

5 月 12 日，Kyverna Therapeutics 公布了 2026 年第一季度财报，并宣布正式启动 miv-cel 针对僵人综合征（SPS）的滚动式生物制品上市申请（BLA）递交，凭借再生医学先进疗法（RMAT）资格申请优先审评，预计 2026 年第四季度完成全部 BLA 提交。 Miv-cel 是一款采用全人源化设计及 CD28 共刺激结构域的自体 CD19 CAR-T，被开发用于治疗多种自免疾病。单次输注即可深度耗竭 B 细胞、重塑免疫系统，有望为自身免疫病患者实现无需长期服药、病情持久缓解的治疗目标。今年 4 月，Kyverna 在 2026 年 AAN 年会重磅口头公布 KYSA-8 关键临床试验主要分析结果。在前期积极初步数据基础上，研究证实：单次输注 miv-cel 后，第 16 周所有主要及次要终点均取得统计学显著且持久的临床获益，患者残疾状态得到逆转。此外，截至第 16 周及末次随访，100% 患者无需再接受僵人综合征相关免疫治疗；同时 miv-cel 整体安全性耐受良好。 Kyverna 计划在 2026 年下半年公布为期一年的随访数据，进一步验证长效获益。值得关注的是，德国通过同情用药路径首批接受 miv-cel 治疗的 2 例僵人综合征患者，已分别实现 15 个月、26 个月的持久疗效，无需长期使用免疫药物。公司首席执行官 Warner Biddle 表示：「作为首家为自身免疫性 CAR-T 疗法递交 BLA 申请的企业，与 FDA 就单臂临床试验方案达成共识、明确 miv-cel 递交路径，不仅是 Kyverna 的重要里程碑，也对整个行业意义重大。在推进滚动式 BLA 递交、筹备 2027 年商业化上市的同时，我们正搭建多样化适应症产品矩阵，巩固在自免疾病中的领先地位。长远来看，公司有望建立全新治疗范式。」除了 SPS 外，miv-cel 针对其他自免疾病的临床研究也在快速推进中。全身型重症肌无力 KYSA-6 注册性试验 III 期持续入组 2026 年 4 月，Kyverna 在 AAN 年会公布 KYSA-6 临床试验 II 期长期随访数据：单次给药后，所有关键疗效指标均实现深度且持久的应答，获益可维持长达一年。无论患者既往是否使用过生物制剂，100% 患者的重症肌无力日常生活活动量表（MG-ADL）、定量重症肌无力评分（QMG）均较基线快速、显著下降，疗效优于 2025 年 10 月中期分析结果。生物标志物及机制研究数据也进一步佐证 miv-cel 具备差异化临床优势。公司计划 2026 年下半年公布全身型重症肌无力 II 期更长随访数据，目前已在全球 15 家研究中心同步推进经 FDA 认可的 III 期临床试验患者入组。进展性多发性硬化（PMS） miv-cel 数据表现积极 2026 年 5 月，斯坦福大学血液骨髓移植与细胞治疗研讨会上，Kyverna 公布了 miv-cel 治疗进展性多发性硬化 IIT 研究最长 12 个月随访更新数据：CAR-T 细胞在患者外周血及脑脊液中显著扩增，能够实现免疫重置。5 例可评估疗效患者末次随访时，扩展残疾状态量表（EDSS）评分均改善或维持稳定，100%（4/4）患者疲劳程度均较基线改善，所有患者均停用其他免疫调节药物。另外，miv-cel 耐受性良好。 Kyverna 预计 2026 年下半年披露该项 IIT 研究更多数据及管线最新进展。 III 期自免 CAR-T 推进中 Kyverna 的进展无疑是自免 CAR-T 赛道最快的。与此同时，这一赛道多家头部药企已纷纷发力，将核心管线推进至 III 期，未来或许迎来自免 CAR-T 爆发的时代。 BMS 据公开信息披露，BMS 的 CD19 CAR-T 细胞疗法 Zola-cel 启动了首个 III 期临床试验，针对活动性系统性硬化症（SSc）。该研究旨在评估 Zola-cel 联合磷酸氟达拉滨和环磷酰胺对比标准治疗（托珠单抗、利妥昔单抗、尼达尼布）治疗 SSc 的有效性和安全性。 Zola-cel 是 BMS 基于 NEX-T 平台生产的，其体外制备周期约为 5 天，生产效率和细胞治疗均获得提升，已经在系统性红斑狼疮、特发性炎症性肌病等多种自免疾病中进行验证。此前公布的 I 期研究 Breakfree-1 结果显示，系统性硬化症相关间质性肺病（SSc-ILD）患者接受一次 Zola-cel 治疗后，肺功能实现了前所未有的改善。在 6 例基线患有 ILD 的患者中，治疗 6 个月后中位相对预测 FVC（pFVC）较基线增加了 10%。这一数据意义重大——其它疗法并未报告过 pFVC 显著改善的效果。今年 4 月，BMS 披露了业绩，也更新了 Zola-cel 的关键里程碑预期，其注册性临床数据读出时间从 2028 年提前至 2027 年。 Cartesian Therapeutics Cartesian 的 Descartes-08 是一种潜在 FIC mRNA 工程化 CAR-T 细胞疗法。它通过靶向 BCMA，清除分泌自身抗体的浆细胞。相较于传统 CAR-T 而言，该疗法的给药设计不需要预处理化疗，支持门诊环境下给药，避免了与癌变相关的基因组整合风险。今年 3 月，Cartesian 披露了第一季度财报和更新业务进展，Descartes-08 有 3 项临床项目正在推进。该疗法针对重症肌无力患者的 III 期 AURORA 试验持续入组，计划纳入 100 名乙酰胆碱受体自身抗体阳性（AChR Ab+）重症肌无力患者，采用每周一次、共六次的门诊输注方式给药，评估患者日常生活活动量表（MG-ADL）评分较基线改善 3 分及以上的患者比例。另外，将启动肌炎 II 期 TRITON 试验和继续推进包括青少年皮肌炎在内的自身免疫病的 I/II 期 HELIOS 儿科试验。总结另外，Cabaletta Bio 的 CD19 CAR-T 疗法 rese-cel 也已经进入关键临床研究期，其皮肌炎（DM）和抗合成酶综合征（ASyS）队列正在招募，计划纳入 17 名患者，顺利的话，将在 2027 年提交 BLA。而这款管线，Cabaletta 将采用自动化、可扩展的平台生产，将有望降低生产成本并快速生产。整体而言，自免 CAR-T 已从概念验证快速迈入商业化冲刺的关键拐点，核心逻辑是用「一次性免疫重置」替代传统终身用药，有望重塑千亿级自免治疗格局。目前，国外头部企业进展领先，国内企业密集布局并推进临床，并且叠加了创新的设计、优化的工艺等，在未来两年，这一赛道将迎来里程碑式突破。素材来源官方媒体/网络新闻近期峰会活动

100 项与 Mivocabtagene Autoleucel(Kyverna) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
僵人综合征	申请上市	美国	德昇济医药（无锡）有限公司	2026-05-12
重症肌无力	临床3期	美国	Kyverna Therapeutics, Inc.	2024-08-28
重症肌无力	临床3期	澳大利亚	Kyverna Therapeutics, Inc.	2024-08-28
重症肌无力	临床3期	巴西	Kyverna Therapeutics, Inc.	2024-08-28
重症肌无力	临床3期	德国	Kyverna Therapeutics, Inc.	2024-08-28
肉芽肿伴多血管炎	临床2期	-	Kyverna Therapeutics, Inc.	2025-01-01
显微镜下多血管炎	临床2期	-	Kyverna Therapeutics, Inc.	2025-01-01
类风湿关节炎	临床2期	德国	Kyverna Therapeutics, Inc.	2024-12-04
坐骨跖骨发育不良	临床2期	美国	Kyverna Therapeutics, Inc.	2024-09-25
原发性进行性多发性硬化	临床2期	美国	Kyverna Therapeutics, Inc.	2024-09-20

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临床结果

适应症

分期

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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


NCT06193889 (KYSA-6, Tandem Meetings ASTCT and CIBMTR2026)	临床2期	重症肌无力 AChR \| MuSK autoantibodies	5	KYV-101 (AChR or MuSK autoantibodies + generalized myasthenia gravis)	鏇憲糧鏇網淵鏇襯糧襯(衊壓衊鏇艱夢鬱選廠醖) = 繭鏇觸窪襯壓蓋鑰齋齋遞顧鏇鹹網窪遞築獵窪 (憲餘鏇衊齋鹹簾廠鹹顧 ) 更多	积极	2026-02-04
NCT06588491 (KYSA-8, Company_Website) 人工标引	临床2期	僵人综合征	26	Miv-cel	醖簾鏇廠範淵鏇選襯鏇(顧夢鬱範壓壓淵鬱範願) = 鹽構獵壓範鹹蓋鬱壓鏇簾選餘膚鹽網築製餘鬱 (鑰願夢繭遞醖艱鏇鏇窪 ) 达到	积极	2025-12-15
NCT06193889 (KYSA-6, GlobeNewswire) 人工标引	临床2/3期	重症肌无力	6	KYV-101	襯獵衊淵遞窪艱繭網蓋(淵淵憲膚遞餘襯築淵範) = 鏇鹹顧觸鑰醖鏇衊窪網憲齋齋遞選鬱糧願餘積 (鬱餘糧製選窪顧繭窪簾 ) 更多	积极	2025-10-29
NCT06342960 \| NCT05938725 (KYSA-3, PRNewswire) 人工标引	临床1/2期	狼疮性肾炎	6	KYV-101	鑰繭獵齋製積鏇積憲遞(廠鏇繭艱獵構鹽淵鏇範) = No High-Grade CRS or ICANS Observed. 網齋積獵構窪醖顧選艱 (夢鏇顧觸窪鬱膚壓醖餘 ) 更多	积极	2024-11-14
Company_Website 人工标引	N/A	多发性硬化症 \| 重症肌无力 \| 神经炎性疾病 ... 更多	41	KYV-101	襯遞獵範獵鹹廠壓鹹廠(醖鏇獵鹽衊艱選選壓觸) = In stiff-person syndrome, two patients treated with KYV-101 have demonstrated improved mobility and/or walking speed and reduced autoantibody titers, including one patient at greater than one year post-infusion. A third patient demonstrated reduced autoantibody titers but does not yet have mobility scores available. In myasthenia gravis, three patients treated with KYV-101 have shown reduced pathogenic anti-AChR antibody titers and sustained disease control, including two patients at more than one year post-infusion and all three at greater than 8 months post-infusion. In multiple sclerosis, five patients treated with KYV-101 who failed prior anti-CD20 medications have shown a significant and unprecedented average reduction in oligoclonal bands in the central nervous system (CNS), a potential surrogate biomarker for reduced disease progression. 夢網簾築窪齋簾淵顧獵 (築獵獵齋艱窪衊齋淵膚 ) 更多	积极	2024-09-18
PRNewswire 人工标引	N/A	僵人综合征	1	KYV-101	鏇鏇憲範觸鑰膚範鑰壓(積襯鹽蓋觸範網衊艱艱) = 願餘選憲廠夢範鬱觸衊艱餘願築壓願簾餘鏇淵 (餘範獵簾製遞膚鏇簾鹹 )	积极	2024-06-17
NEWS 1 \| NEWS 2	N/A	狼疮性肾炎	50	KYV-101	簾製窪糧窪鑰製鹽憲廠(願醖構壓淵憲積繭膚鬱) = 觸襯築淵齋願醖襯簾鏇願蓋鏇蓋襯築鑰網襯網 (構鏇積顧鏇網獵衊壓鬱 )	积极	2024-06-14
PRNewswire 人工标引	N/A	重症肌无力	1	KYV-101	糧簾製蓋網夢獵糧襯餘(鹽襯壓鬱齋夢鹽築簾壓) = 願簾襯鬱範遞淵醖醖衊襯艱廠範廠齋製鏇蓋齋 (製鑰窪衊鏇鹽艱淵衊築 ) 更多	积极	2023-11-15
NCT02659943 (CTgov)	临床1期	慢性淋巴细胞白血病 \| B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	27	Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only)	餘膚鹽鹽觸醖窪鹹鏇網 = 製艱衊鬱網鬱餘觸簾憲憲網夢構襯願願齋範繭 (顧糧艱壓積製鬱窪製壓, 鏇簾憲醖鏇鹹構範鏇遞 ~ 遞觸鬱齋網鑰網鏇簾蓋) 更多	-	2021-05-04
NCT02659943 (CTgov)	临床1期	慢性淋巴细胞白血病 \| B细胞淋巴瘤 \| 弥漫性大B细胞淋巴瘤	27	Fludarabine+Cyclophosphamide+Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells (LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells)	餘膚鹽鹽觸醖窪鹹鏇網 = 鹽齋艱膚觸鏇簾網餘願憲網夢構襯願願齋範繭 (顧糧艱壓積製鬱窪製壓, 壓顧鬱艱鹽餘餘淵鑰襯 ~ 獵鏇襯鬱選製夢廠壓餘) 更多	-	2021-05-04