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一项评价靶向BCMA的嵌合抗原受体T细胞注射液(CART-BCMA)治疗复发/难治性多发性骨髓瘤患者的有效性和安全性的Ⅱ期开放、单臂、多中心临床研究
[Translation] A phase II open-label, single-arm, multi-center clinical study evaluating the efficacy and safety of BCMA-targeted chimeric antigen receptor T cell injection (CART-BCMA) in the treatment of patients with relapsed/refractory multiple myeloma
主要目的:评价CART-BCMA治疗复发/难治性多发性骨髓瘤3个月ORR(3个月时间点至少达到PR或更佳);
[Translation] Main purpose: To evaluate the 3-month ORR of CART-BCMA in the treatment of relapsed/refractory multiple myeloma (at least achieve PR or better at the 3-month time point);
靶向BCMA的嵌合抗原受体T细胞注射液(CART-BCMA)在BCMA阳性的复发/难治多发性骨髓瘤患者中的I期临床研究
[Translation] Phase I clinical study of BCMA-targeted chimeric antigen receptor T cell injection (CART-BCMA) in BCMA-positive patients with relapsed/refractory multiple myeloma
主要目的
1.评价复发/难治多发性骨髓瘤患者在输注CART-BCMA后的安全性和耐受性;
2.确定CART-BCMA在复发/难治多发性骨髓瘤患者中的最大耐受剂量(MTD)和/或后续推荐剂量(RD)。
次要目的
1.初步评价CART-BCMA在复发/难治多发性骨髓瘤患者中的有效性。
2.初步评价CART-BCMA细胞和CAR拷贝数在复发/难治多发性骨髓瘤患者中的药代动力学参数。
3.初步评估CART-BCMA的免疫原性。
探索性目的
1.探索评价复发 /难治多发性骨髓瘤患者在经输注 CART-BCMA治疗后的总体生存期(OS);
2.探索评估 CART-BCMA在受试者血液的中扩增情况,及其与疗效、不良反应、相关生物标志水平的关系;
3.探索评估受试者基线 BCMA在骨髓浆细胞和骨髓瘤细胞中的表达及其与 CART-BCMA疗效的关系;
4.探索评估疾病进展/复发时,骨髓浆细胞和骨髓瘤细胞BCMA表达的阴性率。
[Translation] main purpose
1. To evaluate the safety and tolerability of CART-BCMA infusion in patients with relapsed/refractory multiple myeloma;
2. To determine the maximum tolerated dose (MTD) and/or follow-up recommended dose (RD) of CART-BCMA in patients with relapsed/refractory multiple myeloma.
secondary purpose
1. Preliminary evaluation of the effectiveness of CART-BCMA in patients with relapsed/refractory multiple myeloma.
2. Preliminary evaluation of the pharmacokinetic parameters of CART-BCMA cells and CAR copy number in patients with relapsed/refractory multiple myeloma.
3. Preliminary assessment of the immunogenicity of CART-BCMA.
exploratory purpose
1. To explore and evaluate the overall survival (OS) of patients with relapsed/refractory multiple myeloma after infusion of CART-BCMA;
2. Explore and evaluate the expansion of CART-BCMA in the blood of subjects, and its relationship with the efficacy, adverse reactions, and related biomarker levels;
3. To explore and evaluate the expression of baseline BCMA in bone marrow plasma cells and myeloma cells and its relationship with the efficacy of CART-BCMA;
4. To explore the negative rate of BCMA expression in bone marrow plasma cells and myeloma cells when evaluating disease progression/relapse.
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