肿瘤细胞治疗研究
英文原题：Study of PD-1Ab21-BCMA CAR-T Therapy for Consolidation of Multiple Myelomawith Renal Dysfunction
这是一项 II 期注册临床试验，评估 BCMA 免疫治疗用于多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 25 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07489534。
不限性别 · ≥ 14 Years
纳入标准： 1. 年龄>14岁。 2. 确诊多发性骨髓瘤并伴肾功能不全，已接受≥2个疗程的一线临床治疗，疗效评估至少达到部分缓解（PR），预计生存期超过3个月。 3. 医院检查符合以下指标： 1. ECOG体能状态评分0至2或Karnofsky评分>80分。 2. 有足够静脉通路用于单采或静脉采血，且无其他血细胞分离禁忌证。 3. 白细胞≥1×10^9/L，淋巴细胞≥0.3×10^9/L。 4. ALT和AST≤正常值上限的2.5倍。 5. 血清总胆红素≤2.0 mg/dL（34.2 μmol/L）。 6. PT-INR<1.7，或PT较正常值延长<4秒。 排除标准： 1. 妊娠或哺乳期女性（本治疗对胎儿安全性未知；女性参与者输注前48小时内血清或尿液妊娠试验须阴性）。 2. 任何未控制的活动性感染。 3. 活动性乙型或丙型肝炎病毒感染。 4. HIV/AIDS感染。 5. 患有神经系统疾病。 6. 签署知情同意书前2周内全身使用类固醇（可使用吸入性类固醇）。 7. 对免疫治疗或相关药物过敏。 8. 患有需治疗的心脏病或控制不佳的高血压。 9. 目前存在不稳定或活动性溃疡或消化道出血。 10. 有器官移植史或正在等待器官移植。 11. 低钠血症，血钠<125 mmol/L。 12. 基线血钾<3.5 mmol/L（可在参加研究前补钾，使血钾恢复至该水平以上）。 13. 需要抗凝治疗（如华法林或肝素）。 14. 需要长期抗血小板治疗（阿司匹林剂量>300 mg/日；氯吡格雷剂量>75 mg/日）。 此外： 1. 正在参加其他临床试验。 2. 研究者认为不适合参加临床试验的其他原因。
Inclusion Criteria: 1. Age: Over 14 years old 2. Diagnosed with multiple myeloma accompanied by renal dysfunction, received ≥ 2 courses of clinical first-line treatment, evaluated efficacy above PR, and predicted survival of more than three months. 3. The hospital examination meets the following indicators: 1. ECOG physical status score 0-2 or KPS score\>80 points 2. Having sufficient venous access for single or intravenous blood collection, and no other blood cells Separation contraindications 3. WBC≥1×109/L，LY≥0.3×109/L， 4. ALT and AST ≤ 2.5 ULN 5. Serum total bilirubin ≤ 2.0mg/dL (34.2 μmol/L) 6. PT:INR\<1.7 or PT prolonged by\<4s compared to normal value Exclusion Criteria: 1. Pregnant or lactating women (the safety of this treatment for unborn babies is unknown, and the assessment of pregnancy status for female participants is negative in serum or urine pregnancy tests within 48 hours prior to infusion); 2. Any uncontrollable active infection; 3. Presence of active hepatitis B or C virus infection; 4. HIV/AIDS infection; 5. Has neurological disorders; 6. Within 2 weeks prior to signing the informed consent form, systemic use of steroid drugs (inhalable steroids may be used); 7. Allergies to immunotherapy and related drugs; 8. Currently, there are patients with heart disease or poorly controlled hypertension who require treatment; 9. Currently, patients with unstable or active ulcers or gastrointestinal bleeding; 10. Patients with a history of organ transplantation or waiting for organ transplantation; 11. Hyponatremia, blood sodium\<125mmol/L; 12. Baseline blood potassium\<3.5mmol/L (potassium can be supplemented before participating in the study to restore blood potassium levels above this level); 13. The patient needs anticoagulant therapy (such as warfarin or heparin); 14. The patient requires long-term antiplatelet therapy (aspirin, dose\>300mg/d); Clopidogrel, dose\>75mg/d). Additionally, 1. Patients currently participating in other clinical trials; 2. Researchers believe that other reasons are not suitable for clinical trial participants.
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：1-year progression free survival rate (1-year-PFS) · The 1-year progression free survival rate (1-year-PFSR) of PD-1Ab21-BCMA CAR-T cell immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction refers to the proportion of disease progression that occurs within one year after treatment in patients. · 1 year after treatment
次要终点：overall survival (OS)；progression free survival (PFS)；time to progression (TTP)；disease free survival (DFS)；duration of response (DOR)；event free survival (EFS)；recurrence rate；safety
本研究旨在评估靶向BCMA并分泌PD-1和白细胞介素21融合蛋白的CAR-T细胞免疫疗法，用于伴肾功能不全的多发性骨髓瘤患者一线巩固治疗的疗效和安全性。
The purpose of this study is to determine the efficacy and safety of targeted BCMA CART cells secreting PD1 and interleukin 21 fusion protein immunotherapy for first-line consolidation therapy of multiple myeloma with renal dysfunction.
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