肿瘤细胞治疗研究
英文原题：Safety and Efficacy of RN1201 Injection as First-Line Treatment for Newly Diagnosed Multiple Myeloma
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的安全性、可行性及初步疗效。当前状态：招募中。计划入组 18 例。试验地点：中国 · 苏州（共 1 个中心，其中中国 1 个）。登记号：NCT07652138。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 愿意参加试验并提供书面知情同意。 2. 根据2017年修订的WHO标准确诊多发性骨髓瘤（MM）。 3. 筛查时或既往病历记录证实BCMA阳性多发性骨髓瘤。 4. 年龄18至70岁，性别不限。 5. 预期生存期至少12周。 6. 血清总胆红素<正常值上限（ULN）的2倍；血清肌酐在正常范围内。 7. ALT和AST<ULN的3倍。 8. ECOG体能状态评分0至2。 9. 左心室射血分数（LVEF）≥50%，无心包积液。 10. 能够遵守研究访视计划及方案要求。 排除标准： 1. 存在严重活动性感染。 2. 获得性或先天性免疫缺陷。 3. 按NYHA标准为III/IV级心力衰竭。 4. 患有癫痫或其他中枢神经系统疾病。 5. 有原发性癌症史，但以下情况除外：已切除的非黑色素瘤皮肤癌（如基底细胞癌）；已治愈的原位癌（如宫颈癌、膀胱癌、乳腺癌）。 6. 治疗前2周内使用全身高剂量类固醇。 7. 妊娠或哺乳期，或计划在6个月内妊娠。 8. 1个月内参加过其他临床试验。 9. 首次研究药物给药前14天内接受过重大手术。 10. 研究者认为可能增加受试者风险或影响试验结果的任何情况。
Inclusion Criteria:
1. Willingness to participate in the trial and provide written informed consent.
* 2\. Diagnosis of multiple myeloma (MM) per the 2017 revised WHO criteria.
* 3\. BCMA-positive multiple myeloma documented at screening or in prior medical records.
* 4\. Aged 18 - 70 years, any gender.
* 5\. Life expectancy of at least 12 weeks.
* 6\. Serum total bilirubin \< twice the upper limit of normal (ULN); serum creatinine within normal range;
* 7\. alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< three times ULN.
* 8\. ECOG performance status score of 0 - 2.
* 9\. Left ventricular ejection fraction (LVEF) ≥50% with no pericardial effusion.
* 10\. Ability to adhere to the study visit schedule and protocol requirements.
Exclusion Criteria:
1. Patients with serious active infections.
* 2\. Subjects with acquired or congenital immunodeficiency.
* 3\. Subjects with Class III/IV heart failure per NYHA criteria.
* 4\. Subjects with epilepsy or other central nervous system diseases.
* 5\. Subjects with a history of primary cancer, except:
1. Resected non-melanoma (e.g., basal cell carcinoma)
2. Cured carcinoma in situ (e.g., cervical, bladder, breast cancer)
* 6\. Systemic high-dose steroid use within 2 weeks before treatment.
* 7\. Pregnant, breastfeeding women, or those planning pregnancy in 6 months.
* 8\. Participation in other clinical trials within one month.
* 9\. Major surgery within 14 days before the first study drug dose.
* 10\. Any condition the investigator deems may raise subject risks or affect trial results.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 incidence and severity of treatment-emergent adverse events (TEAEs) and doselimiting toxicities (DLTs) · DLTs: Within 28 days after CAR-T cell infusion; TEAEs: From infusion up to 24 months post-treatment.
次要终点：Overall effectiveness and duration of efficacy；Pharmacokinetic (PK) of RN1201；Pharmacodynamic (PD) of RN1201；Pharmacodynamic (PD) of RN1201；Pharmacodynamic (PD) of RN1201
新诊断多发性骨髓瘤患者接受异基因CAR-T细胞治疗。
这是一项单臂、剂量递增探索性研究，评估靶向BCMA/CD19的异基因CAR-T细胞疗法RN1201用于新诊断多发性骨髓瘤患者的安全性和疗效。患者先接受淋巴细胞清除治疗，随后单次输注RN1201。主要终点包括治疗期间出现的不良事件的发生率和严重程度；次要终点评估缓解率及微小残留病（MRD）状态。
This is a single-arm, dose-escalation exploratory study evaluating the safety and efficacy of RN1201, a BCMA/CD19-targeted allogeneic CAR-T cell therapy, in patients with newly diagnosed multiple myeloma. Patients will receive lymphodepletion followed by a single infusion of RN1201. Primary endpoints include incidence and severity of treatment-emergent adverse events. Secondary endpoints assess response rate and minimal residual disease (MRD) status.
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