CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
报名条件（概要）
- 年龄：18 Years – 70 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
其他名称：RD06-05
Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of CD19/BCMA-targeted CAR-T cells (RD06-05) at dose of 1 × 10\^7 CAR+ T cells/kg (Additional dose levels will be determined by safety, PK/PD, and preliminary efficacy).
From Day -5 to Day -3 prior to cell infusion (Day 0), subjects will receive chemotherapy preconditioning based on the "Fludarabine + Cyclophosphamide" (FC regimen). The recommended preconditioning regimen is as follows: Fludarabine: 30 mg/m² per day, once daily for 3 consecutive days; Cyclophosphamide: 300 mg/m² per day, once daily for 3 consecutive days;
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
合作机构
- Nanjing Bioheng Biotech Co., Ltd.企业
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders. In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data. For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.
适应症
主动联系研究团队
总联系人（申办方／研究总部）
- Ke Shangkay_sang@qq.com027-83663337
中国／港澳台研究中心
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan，Hubei，China
问自己是否符合条件、如何预筛
我的病情档案
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases ClinicalTrials.gov Identifier: NCT07337785 Sponsor: Tongji Hospital Investigational product: CD19/BCMA-targeted CAR-T cells, Lymphodepleting Conditioning About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases 试验编号：NCT07337785 申办方：Tongji Hospital 研究药物：CD19/BCMA-targeted CAR-T cells、Lymphodepleting Conditioning 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。