天津注射用贝林妥欧单抗（皮下注射）II期临床试验-一项在R/R 和MRD+ B-ALL 成人和青少年患者中研究贝林妥欧单抗皮下给药的1/2 期研究

登记号	CTR20254217	试验状态	进行中
申请人联系人	李越	首次公示信息日期	2025-10-24
申请人名称	Amgen Inc./ 百济神州（北京）生物科技有限公司

登记号	CTR20254217
相关登记号	暂无
药物名称	注射用贝林妥欧单抗（皮下注射）
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	急性淋巴细胞白血病
试验专业题目	一项在复发或难治性B细胞前体急性淋巴细胞白血病（R/R B-ALL）和微小残留病变阳性（MRD+）BALL成人和青少年患者中研究贝林妥欧单抗皮下给药的安全性、有效性和药代动力学的1/2 期开放性研究
试验通俗题目	一项在R/R 和MRD+ B-ALL 成人和青少年患者中研究贝林妥欧单抗皮下给药的1/2 期研究
试验方案编号	20180257	方案最新版本号	替代修订案12
版本日期:	2025-05-16	方案是否为联合用药	否

申请人名称	[["Amgen Inc."],["百济神州（北京）生物科技有限公司"]]
联系人姓名	李越	联系人座机	010-4008203-159	联系人手机号
联系人Email	Clinicaltrials@beonemed.com	联系人邮政地址	北京市-北京市-昌平区中关村生命科学园，科学园路30号	联系人邮编	102206

本研究I期部分旨在评估皮下注射（SC）贝林妥欧单抗治疗复发或难治性B细胞前体急性淋巴细胞白血病（R/R B-ALL）的安全性、有效性和耐受性，以确定SC给药贝林妥欧单抗的最大耐受剂量（MTD）和II期推荐剂量（RP2D）。 本研究II期部分将评估皮下注射（SC）贝林妥欧单抗治疗12岁及以上复发或难治性B细胞前体急性淋巴细胞白血病（R/R B-ALL）和微小残留病变阳性（MRD+）B-ALL患者的安全性、有效性和耐受性，同时还将对SC1和SC2两种贝林妥欧单抗制剂进行临床药代动力学（PK）评价。

试验分类	安全性和有效性	试验分期	II期	设计类型	单臂试验
随机化	非随机化	盲法	开放	试验范围	国际多中心试验

年龄	12岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["Ph-IIR、Ph-IIC、剂量递增、剂量扩展：受试者必须患有R/R B-ALL。"],["首次挽救治疗后任何时间出现复发或难治性的B-ALL。"],["在alloHSCT后任何时间出现的复发B-ALL。"],["Ph-IIR、Ph-IIC、剂量递增、剂量扩展：根据当地评估，BM中原始细胞≥5%。"],["Ph-IIM：受试者必须患有B-ALL，且根据当地评估，BMB≥0.01%且<5%。"],["Ph-IIM：需要提供来自初次诊断或复发诊断的适当的存档骨髓标本，以及筛选期骨髓样本。"],["年龄≥18岁：ECOG体能状态评分≤2。"],["年龄16至<18岁：Karnofsky体能状态评分≥50%。"],["年龄<16岁：Lansky体能状态评分≥50%。"],["对既往酪氨酸激酶抑制剂（TKI）不耐受或难治性的Ph+受试者均有资格入组。"],["Ph-IIM：BM 功能定义如下：n中性粒细胞绝对计数（ANC）≥500/μL;n血小板计数≥50 000/μL（允许输血）;n血红蛋白水平≥9 g/dL（允许输血）."],["Ph-IIRb和Ph-IIMb：签署ICF时年龄≥12岁且<17岁。Ph-IIRa和Ph-IIMa：签署ICF时年龄≥17岁。剂量递增和剂量扩展：签署ICF时年龄≥18岁（或≥国家法定年龄，前提是其超过18岁）。"]]
排除标准	[["CNS内的活动性ALL。在CSF中每立方毫米存在>5个白细胞伴有淋巴母细胞（经CSF分析确认）和/或CNS白血病的临床症状。如果存在CSF白血病，受试者必须接受鞘内治疗，并在入组前有CSF阴性证明。"],["有临床相关的CNS病理或事件的病史或目前存在临床相关的CNS病理或事件，如癫痫、儿童或成人痫性发作、轻瘫、失语、中风、重度脑损伤、痴呆、帕金森病、小脑疾病、器质性脑综合征、精神病或重度（≥3级）CNS事件（不包括头痛），包括既往CAR-T或其他T细胞衔接器治疗导致的ICANS。"],["孤立的EM疾病。"],["仅Ph-IIM：现患EM疾病或存在循环白血病原始细胞。"],["当前存在自身免疫性疾病或有可能累及CNS的自身免疫性疾病史。"],["需要使用免疫抑制药物进行全身治疗的活动性急性或慢性移植物抗宿主病。"],["出现提示急性或无法控制的慢性感染的症状和/或临床体征，任何其他合并疾病或可能因治疗而加重或严重影响方案依从性的医疗状况。"],["睾丸白血病。"],["在开始方案规定的治疗前3年内除ALL外的恶性肿瘤病史（有某些例外情况）。"],["在开始方案规定的治疗前12周内接受过alloHSCT。"],["在开始方案规定的治疗前2周内进行抗肿瘤化疗（有某些例外情况）。"],["在方案规定的治疗开始前4周内接受过免疫治疗。"],["若患者既往接受过失败的CD19靶向治疗（例如既往贝林妥欧单抗或CD19 CAR-T细胞治疗），且证明持续存在CD19+表达，且治疗在方案治疗开始前>4周结束，且无既往CNS并发症，则允许参与研究。"],["目前正在另一项试验器械或药物研究中接受治疗，或自另一项试验器械或药物研究治疗结束后不到30天或5个半衰期。"],["筛选期实验室检查值异常。"],["女性受试者：目前怀孕、正在哺乳，或计划在治疗期间及试验用药品（贝林妥欧单抗SC给药）末次给药后96小时内怀孕、捐卵或哺乳。"]]

试验药	[["中文通用名:贝林妥欧单抗（AMG103) 英文通用名:Blinatumomab(AMG103) 商品名称:BLINCYTO","剂型:注射剂 规格:0.75mg/瓶 用法用量:1.体重≥45kg：第1周期第1周每日250μg（QD），第2-4周及后续周期每周3次（TIW）500μg；2.体重用药时程:每周期35天（4周治疗+1周间歇），最多5个周期。"]] 序号 名称 用法
对照药	暂未填写此信息 序号 名称 用法

主要终点指标及评价时间

[["出现剂量限制性毒性（DLT）的受试者数量","最长29天","安全性指标"],["治疗中出现不良事件的受试者数量","最长29天","安全性指标"],["治疗中出现严重不良事件、治疗相关的不良事件和需关注的不良事件的受试者数量","最长大约28周","安全性指标"],["完全缓解/完全缓解伴血液学部分恢复（CR/CRh）的受试者数量","最长大约28周","有效性指标"],["贝林妥欧单抗皮下制剂1和2的最大浓度","最长10周","有效性指标+安全性指标"],["贝林妥欧单抗皮下制剂1和2的平均浓度","最长大约4周","有效性指标+安全性指标"],["贝林妥欧单抗皮下制剂1和2达到最大浓度的时间","最长大约4周","有效性指标+安全性指标"],["贝林妥欧单抗皮下制剂1和2的血药浓度-时间曲线下面积","最长大约4周","有效性指标+安全性指标"],["完全缓解伴微小/可测量残留病变阴性缓解的受试者数量","最长大约4周","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["贝林妥欧单抗皮下给药后的PK 参数包括但n不限于：Cmin、Cmax、Tmax、AUC。","最长大约10周","有效性指标+安全性指标"],["完全缓解/完全缓解伴血液学部分恢复/不完全恢复（CR/CRh/CRi），无原始细胞n低增生或再生障碍性BM，伴MRD 阴性n缓解的受试者数量","最长10周","有效性指标"],["抗贝林妥欧单抗抗体形成的受试者数量","最长大约28周","安全性指标"],["总生存期、缓解持续时间、无复发生存期","最长大约2年","有效性指标"],["治疗中出现不良事件、治疗相关的不良事件和需关注的不良事件的受试者数量","最长大约28周","安全性指标"],["治疗中出现严重不良事件的受试者数量","最长大约2年","安全性指标"],["通过EORTC QLQ-C30（针对签署ICF 时n年龄≥17 岁的受试者）和PedsQL 通用核n心量表（针对签署ICF 时年龄12 至<17 岁n的受试者）评估的每次评估时的汇总评分n和较基线变化","从基线到最长大约28周","有效性指标+安全性指标"],["参与密集PK 采样评估的受试者中贝林妥欧n单抗SC 给药后的PK 参数，包括但不限于nCmax、Tmax 和AUCn？ 未参与密集PK 采样评估的受试者中贝林妥n欧单抗血清浓度","最长大约4周","有效性指标+安全性指标"],["通过FACIT-GP5 量表测定的受试者（在签n署ICF 时年龄≥17 岁）从基线至治疗结束因n治疗产生严重副作用的时间比例","从基线到最长大约28周","安全性指标"],["通过NRS-11 报告的受试者（签署ICF 时年n龄为12 至<17 岁）注射前后疼痛评分的差值","最长大约28周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王建祥	学位	医学博士	职称	主任医师
	电话	13821389157	Email	wangjx@ihcams.ac.cn	邮政地址	天津市-天津市-静海区团泊大道 28 号
	邮编	300020	单位名称	中国医学科学院血液病医院

[["中国医学科学院血液病医院","王建祥","中国","天津市","天津市"],["中国医学科学院血液病医院","竺晓凡","中国","天津市","天津市"],["南方医科大学珠江医院","李玉华","中国","广东省","广州市"],["福建医科大学附属协和医院","吴勇","中国","福建省","福州市"],["徐州医科大学附属医院","陈伟","中国","江苏省","徐州市"],["苏州大学附属儿童医院","胡绍燕","中国","江苏省","徐州市"],["南方医科大学南方医院","吴学东","中国","广东省","广州市"],["南方医科大学南方医院","周红升","中国","广东省","广州市"],["华中科技大学同济医学院附属协和医院","梅恒","中国","湖北省","武汉市"],["华中科技大学同济医学院附属协和医院","吴小艳","中国","湖北省","武汉市"],["西安交通大学第一附属医院","贺鹏程","中国","陕西省","西安市"],["四川大学华西医院","吴俣","中国","四川省","成都市"],["首都医科大学附属北京儿童医院","张瑞东","中国","北京市","北京市"],["浙江大学医学院附属第一医院","金洁","中国","浙江省","杭州市"],["郑州大学第一附属医院","马杰","中国","河南省","郑州市"],["河南省肿瘤医院","魏旭东","中国","河南省","郑州市"],["青岛大学附属医院","王伟","中国","山东省","青岛市"],["苏州大学附属第一医院","陈苏宁","中国","江苏省","苏州市"],["浙江大学医学院附属儿童医院","徐晓军","中国","浙江省","杭州市"],["Instituto Alexander Fleming","Santiago Cranco","Argentina","Buenos Aires","Buenos Aires"],["Hospital Italiano de Buenos Aires","Alberto DanieltGimenez Conca","Argentina","Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Sanatorio Allende","Gustavo Daniel Jarchum","Argentina","Córdoba","Córdoba"],["Cemic - Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno","Nicolas Cazap","Argentina","Ciudad Autonoma Buenos Aires","Ciudad Autonoma Buenos Aires"],["Monash Medical Centre","Pasquale Fedele","Australia","VIC","Clayton"],["The Alfred Hospital","Shaun Fleming","Australia","VIC","Melbourne"],["Austin Health, Austin Hospital","Chun Yew Fong","Australia","VIC","Heidelberg"],["Royal Adelaide Hospital","David Tak On Yeung","Australia","SA","Adelaide"],["Westmead Hospital","John Kwan","Australia","NSW","Westmead"],["Sydney Childrens Hospital","Draga Barbaric","Australia","NSW","Randwick"],["The Royal Childrens Hospital","Seong Lin Khaw","Australia","VIC","Parkville"],["Perth Childrens Hospital","Rishi Kotecha","Australia","WA","Nedlands"],["Queensland Childrens Hospital","Christopher Fraser","Australia","QLD","South Brisbane"],["Royal Perao th Hospital","Agnes Siew Mee Yong","Australia","SA","Adelaide"],["Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur","Carlos Graux","Belgium","Yvoir","Yvoir"],["Hosp Clin Fac Med Ribeirao Preto Usp","LeonardotCarvalho Palma","Brazil","SPaulo","Ribeirao Preto"],["Hospital Sirio Libanes","ViniciustBurnett Aboud Souza da Eira","Brazil","Distrito Federal","Brasilia"],["Fundacao Amaral Carvalho","Ederson Roberto Mattos","Brazil","Sao Paulo","Jau"],["Instituto Cancer Sao Paulo Icesp","WellingtontFernandes da Silva Junior","Brazil","Sao Paulo","Sao Paulo"],["Instituto Medicina Integral Imip","Mecneide Lins","Brazil","Pernambuco","Recife"],["Instituto Onco Ped Graac Unifesp","Ana Virginia Lopes de Sousa","Brazil","Sao Paulo","Sao Paulo"],["Hosp de Clinicas de Porto Alegre","Mariana Michalowski","Brazil","Rio Grande do Sul","Porto Alegre"],["University of Alberta","Joseph Brandwein","Canada","AB","Edmonton"],["Arthur J E Child Comprehensive Cancer Centre","Mary-Lynn Savoie","Canada","AB","Calgary"],["Vancouver General Hospital, Gordon and Leslie Diamond Health Care Centre","Yasser Abou Mourad","Canada","BC","Vancouver"],["Princess Margaret Cancer Centre","Andre Schuh","Canada","ON","Toronto"],["Centre Hospitalier Universitaire Saint-Justine","HenriquetBittencourt","Canada","QC","Montreal"],["Stollery Childrens Hospital","Sunil Desai","Canada","AB","Edmonton"],["The Hospital for Sick Children","Sumit Gupta","Canada","ON","Toronto"],["Alberta Childrens Hospital","Victor Lewis","Canada","AB","Calgary"],["Fakultni nemocnice Brno","Michael Doubek","Czech Republic","Brno","Brno"],["Fakultni nemocnice Ostrava","Zdenek Koristek","Czech Republic","Ostrava","Ostrava"],["Centre Hospitalier Universitaire de Nice - Hopital l Archet","Thomas Cluzeau","France","Nice cedex 3","Nice cedex 3"],["Institut Universitaire du Cancer Toulouse Oncopole","FrancoisetHuguet","France","Toulouse cedex 9","Toulouse cedex 9"],["Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez","Celine Berthon","France","Lille","Lille"],["Hopital Saint Antoine","Eolia Brissot","France","Paris","Paris"],["Hopital Saint Louis","Nicolas Boissel","France","Paris","Paris"],["Hopital Lyon Sud","Marie Balsat","France","Pierre Benite","Pierre Benite"],["Centre Hospitalier de Versailles - Hopital Andre Mignot","Aurelie Cabannes-Hamy","France","Le Chesnay Cedex","Le Chesnay Cedex"],["Hopital Robert Debre","Marion Strullu","France","Paris","Paris"],["Universitatsklinikum Ulm","Andreas Viardot","Germany","Ulm","Ulm"],["Charite – Universitaetsmedizin Berlin, Campus Benjamin Franklin","Stefan Schwartz","Germany","Berlin","Berlin"],["Universitaetsklinikum Leipzig","Vladan Vucinic","Germany","Leipzig","Leipzig"],["Universitaetsklinikum Koeln","Boris Boell","Germany","Koeln","Koeln"],["Universitaetsklinikum Jena","Ulf Schnetzke","Germany","Jena","Jena"],["Universitaetsklinikum Augsburg","Andreas Rank","Germany","Augsburg","Augsburg"],["Charite – Universitaetsmedizin Berlin, Campus Virchow","Andrej Lissat","Germany","Berlin","Berlin"],["Universitaetsklinikum Tuebingen","Markus Mezger","Germany","Tuebingen","Tuebingen"],["Queen Mary Hospital, The University of Hong Kong","Yok Lam Kwong","中国香港","Hong Kong","Hong Kong"],["Hong Kong Childrens Hospital","Chi-KongtLi","中国香港","Hong Kong","Kowloon Bay"],["Rambam Medical Center","AvrahamtFrisch","Israel","Haifa","Haifa"],["Rabin Medical Center - Beilinson Hospital","Ofir Wolach","Israel","Petah Tikva","Petah Tikva"],["Tel-Aviv Sourasky Medical Center","Yakir Moshe","Israel","Tel Aviv","Tel Aviv"],["Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii","Alessandro Rambaldi","Italy","Bergamo","Bergamo"],["Azienda Ospedaliera Policlinico Umberto I","Sabina Chiaretti","Italy","Roma","Roma"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","Chiara Cattaneo","Italy","Brescia","Brescia"],["IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola","Cristina Papayannidis","Italy","Bologna","Bologna"],["IRCCS Ospedale Pediatrico Bambino Gesu","Franco Locatelli","Italy","Roma","Roma"],["Fondazione IRCCS San Gerardo dei Tintori","Carmelo Rizzari","Italy","Monza (MB)","Monza (MB)"],["IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola","Arcangelo Prete","Italy","Bologna","Bologna"],["Azienda Ospedaliera di Rilievo Nazionale Santobono Pausilipon","Rosanna Parasole","Italy","Napoli","Napoli"],["Azienda Ospedaliero Universitaria Policlinico G Rodolico - San Marco Presidio Ospedaliero G Rodolico","LucatLo Nigro","Italy","Catania","Catania"],["National Cancer Center Hospital East","JunichirotYuda","Japan","Chiba","Kashiwa-shi"],["Yokohama City University Medical Center","Takuya Miyazaki","Japan","Kanagawa","Yokohama-shi"],["Akita University Hospital","Akihiro Kitadate","Japan","Akita","Akita-shi"],["Fukushima Medical University Hospital","Takayuki Ikezoe","Japan","Fukushima","Fukushima-shi"],["Kanagawa Childrens Medical Center","Masakatsu Yanagimachi","Japan","Kanagawa","Yokohami-shi"],["Hospital Universitario Dr Jose Eleuterio Gonzalez","David Gomez Almaguer","Mexico","Nuevo Leon","Monterrey"],["Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran","Maria RobertatDemichelis Gomez","Mexico","Mexico","Ciudad de Mexico"],["Christus Centro de Excelencia en Investigacion","Willy Nava Gutierrez","Mexico","Nuevo Leon","Monterrey"],["Health Pharma Queretaro Sa de Cv","Jocelyn Aguilar Luevano","Mexico","Queretaro","Juriquilla"],["Hospital Infantil Teleton de Oncologia","Maria del PilartCubria Juarez","Mexico","Queretaro","Queretaro"],["Erasmus Medisch Centrum","Anita Rijneveld","Netherlands","Rotterdam","Rotterdam"],["Prinses Maxima Centrum","Erica Brivio","Netherlands","Utrecht","Utrecht"],["Institutul Regional de Oncologie Iasi","Angela Smaranda Dascalescu","Romania","Iasi","Iasi"],["Institutul Oncologic Prof Dr Ion Chiricuta","Ciprian Tomuleasa","Romania","Cluj-Napoca","Cluj-Napoca"],["Spitalul Universitar de Urgenta Bucuresti","Horia Bumbea","Romania","Bucharest","Bucharest"],["The Catholic University of Korea Seoul St Marys Hospital","Jae-Ho Yoon","South Korea","Seoul","Seoul"],["Seoul National University Hospital","Youngil Koh","South Korea","Seoul","Seoul"],["Chonnam National University Hwasun Hospital","Sung-Hoon Jung","South Korea","Hwasun-gun, Jeollanam-do","Hwasun-gun, Jeollanam-do"],["Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca","Jesus Maria Hernandez Rivas","Spain","Castilla Leon","Salamanca"],["Hospital Universitario 12 de Octubre","Maria Pilar Martinez Sanchez","Spain","Madrid","Madrid"],["Clinica Universidad de Navarra","Jose JuantRifon Roca","Spain","Navarra","Pamplona"],["Hospital Clinico Universitario de Valencia","Maria del MartTormo Diaz","Spain","Comunidad Valenciana","Valencia"],["Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol","Anna Torrent Catarineu","Spain","Cataluna","Badalona"],["Hospital Universitari Vall d Hebron","AlbatPuyuelo Benito","Spain","Cataluna","Badalona"],["Hospital Universitario Marques de Valdecilla","Maria Aranzazu Bermudez Rodriguez","Spain","Cantabria","Santander"],["Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals","Clara Maluquer Artigal","Spain","Cataluna","Hospitalet de Llobregat"],["Hospital Sant Joan de Deu","Jose Luis Dapena Diaz","Spain","Cataluna","Esplugues de Llobregat"],["Hospital Universitario Infantil Nino Jesus","Beatriz Vergara Munoz","Spain","Madrid","Madrid"],["Izmir Ekonomi Universitesi Medical Point Hastanesi","Seckin Cagirgan","Turkiye","Izmir","Izmir"],["Bagcilar Medipol Mega Universite Hastanesi","Senem Maral","Turkiye","Istanbul","Istanbul"],["Ankara Bilkent Sehir Hastanesi","Gulsum Ozet","Turkiye","Ankara","Ankara"],["Saglik Bilimleri Universitesi Gulhane Egitim ve Arastirma Hastanesi","Melda Comert","Turkiye","Ankara","Ankara"],["Istanbul Florence Nightingale Hastanesi","Omur Sevindik","Turkiye","Istanbul","Istanbul"],["University College Hospital","Rachael Hough","United Kingdom","London","London"],["Royal Marsden Hospital","Catherine Garnett","United Kingdom","Sutton","Sutton"],["University of Texas MD Anderson Cancer Center","EliastJabbour","USA","TX","Houston"],["Fred Hutchinson Cancer Center","Ryan Cassaday","USA","WA","Seattle"],["City of Hope National Medical Center","Vaibhav Agrawal","USA","CA","Duarte"],["New York University Grossman School of Medicine and New York University Langone Hospitals","Mohammad Abdul Hay","USA","NY","New York"],["The Medical College of Wisconsin","Ehab Atallah","USA","WI","Milwaukee"],["Johns Hopkins University","JonathantWebster","USA","MD","Baltimore"],["University of Illinois Chicago","John Quigley","USA","IL","Chicago"],["University of Colorado Cancer Center","Marc Schwartz","USA","CO","Aurora"],["Massachusetts General Hospital","Hanno Hock","USA","MA","Boston"],["Roswell Park Comprehensive Cancer Center","Eunice Wang","USA","NY","Buffalo"],["Albert Einstein College of Medicine - Montefiore Medical Center","Ioannis Mantzaris","USA","NY","Bronx"],["Childrens Hospital of Philadelphia","Susan Rheingold","USA","PA","Philadelphia"],["St Jude Childrens Research Hospital","SethtKarol","USA","TN","Memphis"],["Childrens Hospital of Los Angeles","ElizabethtEom","USA","CA","Los Angeles"],["University of Colorado","Kelly Faulk","USA","CO","Aurora"],["University of Utah Medical Center Primary Childrens Medical Center","Luke Maese","USA","UT","Salt Lake City"],["C.S. Mott Children's Hospital - University of Michican","Joshua Goldman","USA","MI","Ann Arbor"],["Lucile Packard Childrens Hospital Stanford","Tanja Gruber","USA","CA","Palo Alto"],["Memorial Sloan Kettering Cancer Center","Jae Park","USA","NY","New York"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院血液病医院（中国医学科学院血液学研究所）伦理审查委员会","同意","2025-08-18"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 26 ； 国际: 156 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 1 ；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：2025-09-23；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-09-23；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；