肿瘤细胞治疗研究
英文原题：Phase II Clinical Study on the Safety and Efficacy of Combined CAR-T Therapy Following Autologous Stem Cell Transplantation in Multiple Myeloma
⚠ 该试验的登记信息已有 15 个月未更新， 页面上显示的「尚未开始招募」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。
这是一项分期未标注的注册临床试验，评估自体造血干细胞治疗多发性骨髓瘤、造血干细胞移植的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 20 例。试验地点：中国 · 徐州（共 1 个中心，其中中国 1 个）。登记号：NCT07034755。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： * 年龄18–70岁； * 预期生存期>12周； * 经体格检查、病理检查、实验室检查及影像学检查确诊多发性骨髓瘤； * 化疗后状态：一线化疗4个周期后达到PR或更佳但未达到CR；或一线化疗4个周期后达到CR但伴有高危因素； * 肝功能：ALT和AST<正常值上限3倍，胆红素<2.0 mg/dL； * 体能状态：Karnofsky体能状态（KPS）>50%； * 器官功能：无严重肝、肾或心脏疾病； * 符合干细胞移植条件； * 静脉通路允许采血，且无白细胞单采禁忌证； * 能够理解并自愿签署书面知情同意书。 排除标准： * 妊娠或哺乳期，或女性计划未来6个月内妊娠； * 感染性疾病（如HIV、活动性结核）； * 活动性乙型或丙型肝炎感染； * 可行性评估显示淋巴细胞靶向转染率<10%，或在CD3/CD28共刺激下扩增不足（<5倍）； * 生命体征异常或无法配合检查； * 精神/心理障碍导致无法遵守治疗或疗效评估； * 严重过敏体质或严重过敏史，尤其是对IL-2过敏； * 严重全身或局部感染，需要抗感染治疗； * 严重自身免疫性疾病； * 研究者认为不适合入组的其他情况。
Inclusion Criteria: * Age: 18-70 years old * Expected survival: \>12 weeks * Diagnosis: Multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies * Post-chemotherapy status: * Patients who achieved partial response (PR) or better but failed to reach complete response (CR) after four cycles of first-line chemotherapy Patients who achieved CR after four cycles of first-line chemotherapy but have high-risk factors * Liver function: * ALT and AST \< 3 times the upper limit of normal * Bilirubin \< 2.0 mg/dl * Performance status: Karnofsky Performance Status (KPS) \>50% * Organ function: No severe liver, kidney, or heart diseases * Stem cell transplantation: Eligible for stem cell transplantation * Venous access: Able to undergo venous blood sampling without contraindications to leukapheresis * Informed consent: Capable of understanding and voluntarily signing a written informed consent form Exclusion Criteria: * Pregnancy or lactation, or women planning pregnancy within the next 6 months * Infectious diseases(e.g., HIV, active tuberculosis) * Active hepatitis B or C infection * Feasibility assessment showing lymphocyte-targeted transfection rate \<10% or insufficient expansion (\<5-fold) under CD3/CD28 co-stimulation * Abnormal vital signs or inability to cooperate with examinations * Psychiatric/psychological disorders precluding treatment compliance or efficacy evaluation * Severe allergic constitution or history of severe allergies, especially to IL-2 * Systemic or localized severe infection requiring anti-infective therapy * Severe autoimmune diseases * Other conditions deemed unsuitable for inclusion by the investigator
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：Progression-Free Survival(PFS):Time between treatment and disease progression or death · The efficacy of autologous hematopoietic stem cell transplantation (ASCT) followed by CAR-T therapy was evaluated in patients with multiple myeloma who either achieved partial response (PR) or better (but not complete response \[CR\]) after four cycles of first-line chemotherapy, or those who achieved CR but had high-risk factors. · Pre-hematopoietic stem cell transplant evaluation、assessed at two weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after CAR-T infusion；MRD · Refers to residual tumor cells or small lesions that still exist in the patient's body after treatment but cannot be detected by imaging methods · Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion；OS · The time from the time the patient receives treatment to the patient's death due to any cause · Efficacy was re-evaluated at 2 weeks, 1 month, 2 months, 3 months, 6 months and 1 year after CAR-T infusion
次要终点：To assess the safety of transplantation in combination with CAR-T
本研究评估自体造血干细胞移植（auto-HSCT）后序贯CAR-T治疗新诊断多发性骨髓瘤患者的疗效和安全性；患者需一线化疗4个周期后达到PR或更佳但未达到CR，或达到CR但存在高危因素。本研究数据将为该类患者的新治疗策略提供支持性证据。
嵌合抗原受体T细胞（CAR-T）免疫治疗是近年来肿瘤过继免疫治疗中快速发展的新方法，其主要特点是通过基因工程使T细胞表达肿瘤抗原特异性受体，从而赋予其靶向能力、细胞毒性和持久性。该疗法在复发/难治性血液系统恶性肿瘤中取得显著疗效。针对多发性骨髓瘤（MM）的CAR-T研究也逐步开展并取得良好结果，使CAR-T成为MM的一种有效新疗法，其中BCMA和GPRC5D等靶点已成为重要治疗靶点。本研究拟评估序贯CAR-T治疗的疗效和安全性：对象为新诊断MM患者，一线化疗4个周期后达到部分缓解（PR）或更佳但未达完全缓解（CR），或虽达CR但伴高危因素；患者先接受自体造血干细胞移植（ASCT），随后接受CAR-T治疗。本研究临床数据将为该类MM患者的新治疗策略提供循证支持。
Chimeric Antigen Receptor T-Cell (CAR-T) immunotherapy is a rapidly developing novel approach in adoptive immunotherapy for tumors in recent years. Its main characteristic lies in genetically engineering T cells to express tumor antigen-specific receptors, thereby endowing them with targeting capability, cytotoxicity, and persistence. This approach has demonstrated remarkable efficacy in relapsed/refractory hematologic malignancies. Research on multiple myeloma (MM)-specific CAR-T cells has also been progressively conducted with promising outcomes, establishing CAR-T cell therapy as an effective new treatment strategy for MM. Notably, targets such as B-cell maturation antigen (BCMA) and GPRC5D have emerged as prominent therapeutic targets for CAR-T cell therapy. Therefore, we propose to evaluate the efficacy and safety of sequential CAR-T therapy following autologous hematopoietic stem cell transplantation (ASCT) in newly diagnosed MM patients who achieve partial response (PR) or better after four cycles of first-line chemotherapy but fail to attain complete response (CR), or those who achieve CR but present with high-risk factors. The clinical data from this study will provide evidence-based support for novel treatment strategies in this subset of MM patients.
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