肿瘤细胞治疗研究
英文原题：A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy
A Study of CS1-targeted CAR-T Cells Therapy for Relapsed Multiple Myeloma After BCMA CAR-T Cells Therapy
⚠ 该试验的登记信息已有 71 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。
这是一项早期 I 期注册临床试验，评估 CAR-T 细胞治疗多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 50 例。试验地点：中国 · 杭州（共 1 个中心，其中中国 1 个）。登记号：NCT04541368。
不限性别 · ≥ 30 Years 且 ≤ 75 Years
纳入标准：组织学确诊CS1阳性多发性骨髓瘤（MM），且符合以下情况之一：BCMA CAR-T治疗后复发；或CS1表达阳性且BCMA表达阴性的MM；造血干细胞移植后复发；微小残留病持续阳性复发；有难以通过化疗或放疗清除的髓外病灶；预期生存期超过12周；年龄30-75岁，性别不限；自愿参加试验并提供知情同意。排除标准：创伤性脑损伤、意识障碍、癫痫、脑血管缺血或出血性疾病史；心电图显示QT间期延长或既往严重心脏病（如严重心律失常）；妊娠或哺乳；严重活动性感染（单纯尿路感染和细菌性咽炎除外）；活动性乙肝或丙肝感染；筛查前2周内接受全身类固醇治疗（近期或目前使用吸入类固醇者除外）；既往接受任何CAR-T产品或其他基因修饰T细胞治疗；肌酐>2.5 mg/dL、ALT/AST>正常值3倍或胆红素>2.0 mg/dL；其他不适合参加试验的未控制疾病；HIV感染；研究者认为可能增加患者风险或干扰研究结果的其他情况。
Inclusion Criteria: 1. Histologically confirmed diagnosis of CS1+ multiple myeloma (MM)： 1. Patients with MM relapsed after BCMA CAR-T therapy;Or MM with positive CS1 expression and negative BCMA expression; 2. Relapsed after hematopoietic stem cell transplantation; 3. Cases with recurrent positive minimal residual disease; 4. Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy. 2. Anticipated survival time more than 12 weeks; 3. Male or female aged 30-75 years; 4. Those who voluntarily participated in this trial and provided informed consent. Exclusion Criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: 1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagicdiseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infectionand bacterial pharyngitis); 5. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; 7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; 8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 9. Other uncontrolled diseases that were not suitable for this trial; 10. Patients with HIV infection; 11. Any situations that the investigator believes may increase the risk of patients or interfere with the results of 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：Dose-limiting toxicity (DLT) · Adverse events assessed according to NCI-CTCAE v5.0 criteria · Baseline up to 28 days after CS1 targeted CAR T-cells infusion；Incidence of treatment-emergent adverse events (TEAEs) · Incidence of treatment-emergent adverse events \[Safety and Tolerability\] · Up to 2 years after CS1 targeted CAR T-cells infusion
次要终点：Overall response rate (ORR)；Overall survival (OS)；Quality of life；Instrumental Activities of Daily Living (IADL) score；Activities of Daily Living (ADL) score；Hospital Anxiety and Depression Scale (HADS) score
采用标准3+3剂量递增设计，共设置3个剂量水平。
临床试验评估CS1靶向CAR-T细胞治疗BCMA CAR-T治疗后复发多发性骨髓瘤的安全性和疗效。
Clinical trial for the safety and efficacy of CS1-targeted CAR-T Cells therapy for relapsed multiple myeloma after BCMA CAR-T cells therapy
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