A Randomized, Open-label Study Evaluating the Efficacy and Safety of Cemacabtagene Ansegedleucel in Participants With Minimal Residual Disease After Response to First Line Therapy for Large B-cell Lymphoma

This is a randomized, open-label study in adult patients who have completed standard first line therapy for large B-cell lymphoma (LBCL) and achieved a complete response or partial response suitable for observation, but who have minimal residual disease (MRD) as detected by the Foresight CLARITY™ Investigational Use Only (IUO) MRD test, powered by PhasED-Seq™. The purpose of the trial is to assess the efficacy and safety of consolidation with cemacabtagene ansegedleucel (cema-cel), an allogeneic CD19 CAR T product, as compared to standard of care observation.
The study is conducted in 2 consecutive parts that will be enrolled continuously. In Part A of the study, participants with MRD are randomized to one of two treatment arms or an observation arm. Treatment includes cema-cel following a lymphodepletion regimen of fludarabine and cyclophosphamide administered with or without the anti-CD52 monoclonal antibody, ALLO-647. Part A will culminate with the selection of the lymphodepletion regimen to advance to Part B. Part B will evaluate the selected lymphodepletion regimen followed by cema-cel as compared with observation.

开始日期2024-06-18

申办/合作机构

Allogene Therapeutics, Inc.

[+1]

NCT05714345

/ Active, not recruiting临床2期

A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

开始日期2023-03-31

申办/合作机构

Allogene Therapeutics, Inc.

NCT05000450

/ Terminated临床1/2期

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

开始日期2021-06-06

申办/合作机构

Allogene Therapeutics, Inc.

100 项与 ALLO-647 相关的临床结果

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100 项与 ALLO-647 相关的转化医学

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100 项与 ALLO-647 相关的专利（医药）

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181

项与 ALLO-647 相关的文献（医药）

2025-07-01·JOURNAL OF NEUROLOGY

Potential use of the SARS-CoV-2 monoclonal antibody sipavibart in people with multiple sclerosis: definition of different patient archetypes from an Italian expert group perspective

Article

作者: Filippi, Massimo ; Centonze, Diego ; Gasperini, Claudio ; Zanetta, Chiara ; Patti, Francesco ; Riva, Agostino ; Gallo, Paolo ; Amato, Maria Pia

INTRODUCTION:

Immunocompromised people, including people with MS (PwMS) remain at increased risk of severe COVID-19 outcomes, highlighting how this population needs additional preventive measures beyond current vaccination. Seven neurologists with experience in the MS field and one infectivologist discussed the use of COVID-19 pre-exposure prophylaxis (PrEP) in PwMS, identifying patients' archetypes for PrEP with the monoclonal antibody sipavibart.

METHODS:

The following topics were discussed: description of the current SARS-CoV-2 infection scenario; identification of the characteristics of the fragile patient; identification of the ideal candidate for PrEP with sipavibart. The recommendations were then produced accordingly.

RESULTS:

Vaccination remains a crucial preventive measure for COVID-19. Age, male sex, and comorbidities are associated with severe outcomes among patients with MS. MS-specific risk factors include higher disability, a progressive disease course, a recent administration of steroids and the treatment with anti-CD20 agents, S1P receptor modulators, cladribine, and anti-CD52 antibodies. Pediatric patients and subjects with neuromyelitis optica spectrum disorder should also be considered fragile subjects. Subjects who could benefit from PrEP include: PwMS who present risk factors similar to the general population or who present disease-specific risk factors, non-vaccinated PwMS, and PwMS under S1P receptor modulators, anti-CD20 agents, alemtuzumab or cladribine and who present at least one risk factor similar to the general population or one disease-specific risk factor.

DISCUSSION:

Subjects with general or disease specific risk factors for severe infections, patients treated with S1P receptor modulators, anti-CD20 agents, alemtuzumab or cladribine, pediatric patients, and pregnant women with MS could represent the ideal candidates for PrEP with sipavibart.

2025-05-10·JOURNAL OF CLINICAL ONCOLOGY

Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies

Article

作者: Le Gall, John B. ; Neelapu, Sattva S. ; Nath, Rajneesh ; Perales, Miguel-Angel ; Miklos, David B. ; Shouse, Geoffrey P. ; Fisher, Paul W. ; de Vos, Sven ; Tees, Michael T. ; Stevens, Don A. ; Feng, Amy ; Hamadani, Mehdi ; Lekakis, Lazaros J. ; Locke, Frederick L. ; Munoz, Javier L. ; Navale, Lynn ; Malik, Shahbaz A. ; Oluwole, Olalekan O.

PURPOSE:

Off-the-shelf, allogeneic CD19 chimeric antigen receptor (CAR) T-cell products may improve access to treatment versus autologous ones. We report the phase I experience of the allogeneic CD19 CAR T-cell product cemacabtagene ansegedleucel (cema-cel) and its predecessor, ALLO-501, in CD19 CAR T-naïve patients with relapsed/refractory large B-cell lymphoma (R/R LBCL).

METHODS:

In the ALPHA2/ALPHA studies, the safety and efficacy of allogeneic CD19 CAR T cells were evaluated in CD19 CAR T treatment-naïve patients with R/R LBCL. Patients received healthy donor-derived, human leukocyte antigen–unmatched cema-cel/ALLO-501 following a 3-day lymphodepletion regimen of fludarabine (30 mg/m 2 once daily), cyclophosphamide (300 or 500 mg/m 2 once daily), and escalating doses of the anti-CD52 monoclonal antibody, ALLO-647.

RESULTS:

As of September 26, 2024, 33 CD19 CAR T-naïve patients with LBCL (median age, 66 years; median number of previous therapies, 3) received allogeneic CAR T cells. CAR T-cell expansion was observed following infusion, with persistence observed up to 4 months. The overall and complete response (CR) rates were 58% and 42%, respectively; the median duration of response in patients with a CR was 23.1 months. The most common treatment-emergent adverse events were hematologic toxicities. No cases of graft-versus-host disease, immune effector cell–associated neurotoxicity syndrome, or grade ≥3 cytokine release syndrome were reported.

CONCLUSION:

Allogeneic CD19 CAR T cells demonstrated promising overall and durable CR rates with a manageable safety profile in CD19 CAR T-naïve patients with R/R LBCL, supporting additional evaluation of cema-cel in patients with LBCL.

2025-01-01·ONCOLOGY RESEARCH

T-cell prolymphocytic leukemia, a case report and review of the literature

Review

作者: GONZáLEZ-RODRíGUEZ, Luis Manuel ; Dalia, Samir ; Cannata-Ortiz, Jimena ; LA Osa, Maria JOSé LóPEZ DE ; Arranz, Eva ; Loscertales, Javier ; Ortiz, Javier ; JUáREZ-Salcedo, Luis Miguel ; Alegre, ADRIáN

T-prolymphocytic leukemia is a rare and aggressive hematological malignancy characterized by the clonal proliferation of mature lymphoid T-cells. The pathogenesis of T-PLL is closely linked to specific chromosomal abnormalities, primarily involving the proto-oncogene T-cell leukemia/lymphoma 1 gene family. Recent advancements in molecular profiling have identified additional genomic aberrations, including those affecting the Janus kinase/signal transducers and activators of transcription (JAK/STAT) signaling pathway. This case report presents a patient with T-prolymphocytic leukemia whose cytogenetic and molecular analysis revealed a t(X;14)(q28;q11.2) translocation and a STAT5B mutation. Here, we aim to review the genetic and molecular underpinnings of T-prolymphocytic leukemia, as well as current treatment options, with a focus on the anti-CD52 monoclonal antibody alemtuzumab and JAK inhibitors. While alemtuzumab followed by allogeneic hematopoietic stem cell transplantation remains the standard of care for eligible patients, its efficacy is limited and many patients are ineligible. Emerging therapeutic approaches, such as JAK/STAT inhibitors, offer promising potential for improving patient outcomes.

项与 ALLO-647 相关的新闻（医药）

2025-08-05

·抗体圈

Allogene 因患者死亡停用免疫抑制抗体，CAR-T 研发遇调整

摘要：Allogene Therapeutics 在其 CAR-T 疗法 cema-cel 治疗大 B 细胞淋巴瘤的 II 期 ALPHA3 试验中，因一名患者死亡且死因被认定与免疫抑制抗体 ALLO-647 相关，决定停用该抗体并调整试验方案。此次事件导致公司股价下跌 12%，也引发了行业对 CAR-T 疗法清淋方案选择的关注。一、试验突发死亡事件，矛头指向 ALLO-647 Allogene 的 II 期 ALPHA3 试验正聚焦于其 CAR-T 候选药物 cemacabtagene ansegedleucel（简称 cema-cel），该药物用于治疗大 B 细胞淋巴瘤。在试验中，ALLO-647 作为清淋疗法的一部分，用于为患者接受 cema-cel 治疗做准备。然而，一名患者在接受输注 54 天后死亡。Allogene 在周五的新闻稿中指出，患者死因是 “免疫抑制状态下的播散性腺病毒感染” 引发的肝衰竭。公司强调，此类严重感染在其试验中 “罕见”，但一旦出现，部分与 ALLO-647 导致的免疫抑制相关。 William Blair 的分析师在给投资者的报告中也认同这一结论，认为现有证据支持该事件源于 ALLO-647 介导的 T 细胞长期抑制，而非 cema-cel 本身。二、Allogene 紧急调整：停用 ALLO-647，转向 FC 方案鉴于患者死亡事件，Allogene 已决定终止 ALPHA3 试验中使用 ALLO-647 的试验组，并将该抗体从研发管线中彻底移除。此后，公司将仅采用氟达拉滨与环磷酰胺（FC 方案）作为 cema-cel 治疗的清淋疗法。同时，Allogene 计划在 2026 年上半年对 ALPHA3 试验进行无效性分析，以评估调整后方案的进展。三、市场与分析师的双重反应市场对这一决定迅速做出回应，Allogene 股价在周五交易中下跌 12%。分析师团队虽支持公司停用 ALLO-647 的决定，但也提出担忧：标准 FC 清淋方案可能无法像联合 ALLO-647 时那样，让 cema-cel 实现 “强劲的扩增与持久存在”。不过他们也指出，ALPHA3 试验入组患者的疾病负担较低，“可能无需强化清淋方案”；且若 cema-cel 获批，仅用 FC 方案或因安全性风险更低，带来 “更高的商业接受度”。四、CAR-T 研发再思：平衡疗效与安全此次事件再次凸显了 CAR-T 疗法研发中清淋方案选择的复杂性。清淋疗法的核心是为 CAR-T 细胞 “扫清障碍”，帮助其在体内扩增，但过度免疫抑制可能增加感染风险。 Allogene 的调整意味着其需在 cema-cel 的疗效与患者安全间寻找新平衡点。行业也在关注，这一调整是否会影响 cema-cel 的研发进度，以及 FC 方案能否在保证安全性的同时，支撑药物达到预期疗效。对于 Allogene 而言，2026 年上半年的无效性分析将成为评估这一调整成败的关键节点。参考来源：https://www.biospace.com/drug-development/allogene-scraps-immunosuppressive-antibody-after-patient-death-in-lymphoma-trial 识别微信二维码，添加抗体圈小编，符合条件者即可加入抗体圈微信群！请注明：姓名+研究方向！本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

细胞疗法免疫疗法临床2期临床结果ASH会议

2025-08-05

·BioSpace

Report of Patient Deaths Sends Agios Shares Seesawing

iStock, Andrii Yalanskyi While the deaths occurred in patients who had been treated with Agios’ anemia treatment Pyrukynd, the biotech insisted in an SEC filing midday Monday that the drug’s risk-benefit pro unchanged. Shares of Massachusetts-based Agios Pharmaceuticals were put through the wringer on Monday after the FDA’s Adverse Event Reporting System revealed four deaths in patients who had taken its anemia drug Pyrukynd. Leerink analysts flagged a 23% dip at the stock’s lowest point, with share prices hitting $26.75 at market opening Monday before rebounding to $36.16 by the closing bell, a 3% increase from its closing price last Friday. In pre-market trading Tuesday, Agios shares have dipped 2% Agios filed an SEC document on Monday to address the four deaths, which were first made public by a securities analyst who filed a Freedom of Information Act request to the FDA’s safety database, to which Agios had reported these deaths. In its regulatory filing, Agios reassured investors that the deaths have “not altered the established benefit-risk profile” for Pyrukynd. Two of the deaths were in older patients: one in a 61-year-old man and another in a 93-year-old woman, both of whom were being treated for pyruvate kinase (PK) deficiency. Agios reported these cases to the FAERS on June 28, 2024 and July 17, 2025, respectively, according to the Leerink analysts. The last two fatalities were in much younger women, a 28-year-old and a 26-year-old, who had sickle cell disease and were being treated with Pyrukynd under compassionate use. The latter of these two cases was reported to the FDA on July 15 this year. Leerink said that these latter two deaths are “concerning given the young age of the patients.” But after following up with Agios, the analysts learned that these two younger patients were actually the same person. “The 28-year-old patient was actually a duplicate of the 26-year-old patient which was incorrectly entered into the database,” the Leerink note read, adding that this has in turn “largely offsets our concerns” that these deaths represent “a heightened mortality risk of Pyrukynd.” Despite Agios’ clarifications, “it is difficult to fully dismiss the impact of the safety concerns” on an upcoming PDUFA data for Pyrukynd, Leerink added. Agios is proposing Pyrukynd for the treatment of patients with alpha- or beta-thalassemia regardless of their dependence on transfusions. The FDA is expected to release its verdict on Sept. 7 . The drug was first approved in 2022 for adults with hemolytic anemia with PK deficiency. Patient deaths have been in the news in recent months, the most visible of which have been the three mortalities linked to Sarepta’s gene therapy portfolio: two to its Duchenne muscular dystrophy product Elevidys and one to an investigational limb-girdle muscular dystrophy candidate. Then, late last week, Allogene Therapeutics likewise reported a patient death in a Phase II study of its CAR T therapy cemacabtagene ansegedleucel, though the fatality was ultimately linked to ALLO-647, an anti-CD52 antibody used as an immunosuppressive treatment to prepare patients for the cell therapy.

临床2期上市批准临床结果细胞疗法免疫疗法

2025-08-04

·药时代

患者死亡！通用型CAR-T先驱遇挫

如果您对创新性细胞疗法感兴趣，请联系药时代BD团队（BD@drugtimes.cn）！全文共932字，共0图预计阅读时间：4分钟当地时间2025年8月1日，Allogene Therapeutics（以下简称为“Allogene”）宣布，其在研CD19通用型CAR-T——cemacabtagene ansegedleucel（cema-cel）的ALPHA3研究中出现一例患者死亡案例！ Allogene是通用型CAR-T领域的先驱，于2017年成立，总部位于美国加州南旧金山。通过核心技术平台AIIOCAR T™，目前Allogene已建立多条通用型CAR-T管线。cema-cel是其管线中进展最快的，已处于II期临床阶段。此次出现患者死亡案例的试验，是Allogene正在进行的 II期ALPHA3研究。Allogene公告指出，死亡案例与cema-cel无关，主要由清淋方案中CFA（环磷酰胺+ALLO-647）的ALLO-647引起。具体来看，这起严重的不良反应数据发生在患者输注后的第54天，为由肝功能衰竭引起的死亡，推测是在免疫抑制状态下发生播散性腺病毒感染所致。为应对，Allogene目前已全面停止涉及ALLO-647的研究臂，与FDA及安全监测委员会（DSMB）和指导委员会协商后，准备将清淋方案换回标准清淋方案，即环磷酰胺+氟达拉滨（FC）。并将临床试验改为常规的双臂研究，试验方案为：每组（FC 治疗组 vs 观察组）纳入 110 例 LBCL（大B细胞淋巴瘤）患者，这些患者在完成一线（1L）治疗后达到完全缓解（CR）或部分缓解（PR）状态，但存在微小残留病灶（MRD）。研究的主要终点为“基于盲态独立影像评估委员会（IRC）判定的无事件生存期（EFS）”。目前，据Allogene披露，这项无效性分析将于2026年上半年公布。对于本例患者死亡案例，Allogene总裁、首席执行官兼联合创始人David Chang博士表示：这一事件促使我们提前审查试验数据，并做出了一个果断的决定——这一决定可能最终帮助这款潜在挽救生命的疗法更快惠及患者。采用标准FC淋巴清除方案后，在门诊环境中使用cema-cel的治疗方式将简化研究流程，有望加速试验入组并优化监管审查路径，从而为患者带来治疗模式的革新。” 经历患者死亡案例后，Allogene从战略上将ALPHA3试验的清淋方案该换为标准FC方案标志着Allogene临床策略的重大调整。此后，所有开放入组的试验及研发管线项目均不再使用ALLO-647。公司正转而通过专有Dagger®平台技术推进下一代AlloCAR T候选产品，该技术旨在减少甚至可能完全替代传统淋巴清除方案。这一策略已应用于治疗晚期肾细胞癌的ALLO-316 TRAVERSE试验和治疗自身免疫性疾病的ALLO-329 RESOLUTION试验，两者均利用Dagger®技术降低对传统淋巴清除方案的依赖。参考资料： 1.公司官网 2.其他公开资料图片来源：即梦AI 全球首例临床改善！中山三院联合士泽生物推进通用型iPSC再生神经细胞治疗脊髓损伤 2025-08-04 云顶新耀战略增持I-Mab，成为其第一大股东 2025-08-02 艾伯维放出豪言：明年将成为业内最大的CNS公司！ 2025-08-02 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击这里，查看更多精彩！

细胞疗法免疫疗法临床2期临床结果ASH会议

100 项与 ALLO-647 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
弥漫性大B细胞淋巴瘤	临床2期	美国	Allogene Therapeutics, Inc.	2024-06-18
弥漫性大B细胞淋巴瘤	临床2期	加拿大	Allogene Therapeutics, Inc.	2024-06-18
纵隔大b细胞淋巴瘤	临床2期	美国	Allogene Therapeutics, Inc.	2024-06-18
纵隔大b细胞淋巴瘤	临床2期	加拿大	Allogene Therapeutics, Inc.	2024-06-18
残留肿瘤	临床2期	美国	Allogene Therapeutics, Inc.	2024-06-18
残留肿瘤	临床2期	加拿大	Allogene Therapeutics, Inc.	2024-06-18
难治性多发性骨髓瘤	临床2期	美国	Allogene Therapeutics, Inc.	2021-06-06
复发性多发性骨髓瘤	临床2期	美国	Allogene Therapeutics, Inc.	2021-06-06
慢性淋巴细胞白血病	临床2期	美国	Allogene Therapeutics, Inc.	2020-05-21
慢性淋巴细胞白血病	临床2期	澳大利亚	Allogene Therapeutics, Inc.	2020-05-21

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临床结果

适应症

分期

评价

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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


ALPHA/ALPHA2 (GlobeNewswire) 人工标引	临床1期	大B细胞淋巴瘤 \| 滤泡性淋巴瘤	87	ludarabine + cyclophosphamide + ALLO-647 + ALLO-501/501A	衊憲憲鑰顧築繭憲壓憲(淵衊願窪鹽顧積糧觸獵) = No unexpected safety concerns were observed. Neutropenia and anemia were the most common any-grade treatment-emergent adverse events (or TEAEs) and neutropenia, anemia, and thrombocytopenia were the most common Grade 3 or higher TEAEs. Grade 3 or higher cytopenias decreased over time from Day 28 to Month 4 and were consistent across all subsets of patients. Incidence of Grade 3 or higher cytopenias were consistent with that reported for autologous CAR T cell therapy 製鹽顧鏇繭構膚網鑰襯 (膚鹹繭製壓夢顧鏇繭衊 )	积极	2023-12-09
ALPHA/ALPHA2 (GlobeNewswire) 人工标引	临床1期	大B细胞淋巴瘤 \| 滤泡性淋巴瘤	87	ludarabine + cyclophosphamide + ALLO-647 + ALLO-501/501A (LBCL)		积极	2023-12-09
NCT04416984 (ALPHA2, ASH 12021 \| ASH 22021) 人工标引	临床1/2期	复发性弥漫性大B细胞淋巴瘤三线	20	fludarabine+cyclophosphamide+ALLO-501A+ALLO-647	窪鏇蓋積積壓夢廠醖夢(繭醖鏇窪鬱鑰膚壓蓋夢) = were the most common AE and occurred in 72% of pts 襯鬱淵壓齋簾膚顧齋襯 (淵範夢齋鏇鏇鬱獵願願 )	积极	2021-11-05
NCT03939026 (ALPHA, ASCO 12020 \| ASCO 22020) 人工标引	临床1期	难治性滤泡性淋巴瘤三线	12	fludarabine+cyclophosphamide+ALLO-501+ALLO-647	襯廠鬱淵獵遞膚鬱壓簾(糧淵壓獵糧積衊鹽齋築) = No DLTs or GvHD have been observed to date 憲鑰繭鬱鑰窪構膚觸齋 (衊觸願獵觸窪鬱鏇壓醖 ) 更多	积极	2020-05-29