肿瘤细胞治疗研究
英文原题：CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
CAR T-cell Therapy Targeting CD19 and BCMA in Patients with AIHA Who Have Failed ≥3 Lines of Therapy.
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
⚠ 该试验的登记信息已有 22 个月未更新， 页面上显示的「招募中」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I 期注册临床试验，评估异体 CAR-T 细胞治疗多发性骨髓瘤、急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 15 例。试验地点：中国 · 天津（共 1 个中心，其中中国 1 个）。登记号：NCT06733610。
不限性别 · ≥ 18 Years
纳入标准： * 年龄≥18岁 * 流式细胞术检测患者外周血B细胞CD19或BCMA阳性。 * 诊断为AIHA的患者，包括温抗体型、冷凝集素病、混合型及其他类型的AIHA，诊断标准参照《中国成人自身免疫性溶血性贫血诊疗指南（2023年版）》 * 复发/难治性AIHA的定义为至少接受过3线治疗失败，常规治疗周期至少6个月后仍有症状性贫血（血红蛋白<100g/L）且仍无效或疾病缓解后复发。常规治疗的定义：使用糖皮质激素和/或利妥昔单抗治疗，以及以下任何1-2种或更多免疫调节药物：环磷酰胺、硫唑嘌呤、吗替麦考酚酯、环孢素A、硫唑嘌呤、达那唑、苯达莫司汀、氟达拉滨、硼替佐米，以及生物制剂包括达雷妥尤单抗、BTK抑制剂、Syk抑制剂和补体抑制剂。 * ECOG ≤ 2 * 主要器官功能要求如下： 1. . 骨髓功能需满足：a 中性粒细胞计数 ≥ 1.0 × 10 ^ 9/L；b. 血小板 ≥ 30 × 10 ^ 9/L。 2. 肝功能：ALT ≤ 3 × UL；AST ≤ 3×ULN； 总胆红素 ≤ 2.0 × ULN（排除Gilbert综合征，总胆红素 ≤ 3.0 × ULN）。 3. 肾功能：肌酐清除率（CrCl）≥ 30 ml/min（Cockcroft/Gault公式，排除疾病本身引起的急性CrCl下降）。 * 有生育能力的女性受试者和有生育能力伴侣的男性受试者在研究治疗期间及研究治疗结束后至少6个月内必须使用医学认可的避孕措施或禁欲；有生育能力的女性受试者在研究入组前7天内必须人绒毛膜促性腺激素（HCG）检测阴性且不处于哺乳期。 * 愿意参加本临床研究，签署知情同意书，依从性良好，并配合随访。 排除标准： * 有严重药物过敏史或过敏倾向的受试者。 * 存在或怀疑有未控制或需要治疗的真菌、细菌、病毒或其他感染。 * 由自身免疫性疾病或非自身免疫性疾病引起的中枢神经系统疾病（包括癫痫、精神病、器质性脑综合征、脑血管意外、脑炎、中枢神经系统血管炎）的受试者。 * 心功能不全的受试者 * 先天性免疫球蛋白缺陷的受试者 * 五年内有恶性肿瘤病史 * 终末期肾衰竭的受试者 * 乙肝表面抗原（HBsAg）阳性或乙肝核心抗体（HBcAb）阳性且外周血HBV DNA＞ULN的受试者；丙型肝炎病毒（HCV）抗体阳性且外周血HCV RNA阳性的受试者；人类免疫缺陷病毒（HIV）抗体阳性者；梅毒检测阳性者 * 患有精神疾病和严重认知障碍的受试者 * 入组前五个半衰期内使用过对该疾病有治疗作用的免疫抑制剂或生物制剂的受试者 * 孕妇或计划怀孕的女性 * 活动性感染、活动性风湿免疫性疾病、药物诱发及确诊的淋巴增殖性肿瘤相关继发性AIHA患者 * 研究者认为存在其他原因导致不适合纳入本研究的受试者。
Inclusion Criteria: * Age ≥ 18 years * Flow cytometry detected positive B cell CD19 or BCMA in the patient's peripheral blood. * Patients diagnosed with AIHA, including warm antibody type, cold agglutinin disease, mixed type, and other types of AIHA, with diagnostic criteria referring to the "Chinese Adult Autoimmune Hemolytic Anemia Diagnosis and Treatment Guidelines (2023 Edition)" * The definition of recurrent/refractory AIHA that has received at least 3 failed lines of treatment is symptomatic anemia (hemoglobin\<100g/L) that persists after a routine treatment cycle of at least 6 months and is still ineffective or reappears after disease remission. The definition of conventional treatment: treatment with glucocorticoids and/or rituximab, as well as any 1-2 or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine A, azathioprine, danazol, bendamustine, fludarabine, bortezomib, and biologics including daratumumab, BTK inhibitors, Syk inhibitors, and complement inhibitors. * ECOG ≤ 2 * Functional requirements for major organs are as follows: 1. . The bone marrow function needs to meet: a Neutrophil count ≥ 1.0 × 10 \^ 9/L; b. Platelets ≥ 30 × 10 \^ 9/L. 2. Liver function: ALT ≤ 3 × UL; AST ≤ 3×ULN； Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN). 3. Renal function: creatinine clearance rate (CrCl) ≥ 30 ml/min (Cockcroft/Gault formula, excluding acute CrCl decline caused by the disease itself). * Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating. * Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: * Subjects with a history of severe drug allergies or allergic tendencies. * Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections. * Subjects with central nervous system diseases caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychosis, organic brain syndrome, cerebral vascular accidents, encephalitis, central nervous system vasculitis). * Subjects with insufficient cardiac function * Subjects with congenital immunoglobulin deficiencies * History of malignancy within five years * Subjects with end-stage renal failure * Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA \>ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing * Subjects with psychiatric disorders and severe cognitive impairments * Subjects who have used immunosuppressive agents or biologics with therapeutic effects on the disease within five half-life before enrollment * Pregnant women or women planning to conceive * Active infection, active rheumatic and immune disease, drug induced and diagnosed lymphoproliferative tumor associated secondary AIHA patients * Subjects that the investigator believes have other reasons that make them unsuitable for inclusion in this study.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：The number and severity of dose-limiting toxicity (DLT) events · DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells. · Within 28 Days After UCAR T-cell Infusion；The total number, incidence, and severity of AEs · Up to 12 Months After UCAR T-cell Infusion；Clinical response of AIHA who have failed ≥ 3 lines of therapy · Rates of CR, CRi, PR, ORR · Up to 24 Weeks After UCAR T-cell Infusion
通用型异体抗CD19/BCMA CAR-T 细胞。
以上邮箱 / 电话是登记库里的申办方联系方式（中国内地手机），通常不直达某家医院。中国中心的联系方式请以医院或登记平台最新公示为准。
这是一项研究者发起的试验，旨在评估通用型同种异体抗CD19/BCMA CAR-T 细胞在≥3线治疗失败的AIHA患者中的安全性和有效性。
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy.
MEMBER ACCOUNT
登录成功会直接打开下一页。
