A Phase 1/2 Clinical Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus
This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).
GC012F注射液治疗难治性系统性红斑狼疮的I/II期临床研究
[Translation] Phase I/II clinical study of GC012F injection in the treatment of refractory systemic lupus erythematosus
主要研究目的
1. 评估GC012F注射液治疗难治性系统性红斑狼疮(SLE)研究参与者的安全性与耐受性,确定II期临床研究推荐剂量(Recommended Phase II Dose,RP2D)。
次要研究目的
1. 进一步评估GC012F注射液治疗难治性SLE研究参与者的安全性;
2. 评估GC012F注射液治疗难治性SLE研究参与者的有效性;
3. 评估GC012F注射液的药代动力学特征、药效动力学特征及在研究参与者体内的扩增及持续性;
4. 评估GC012F注射液在研究参与者体内的免疫原性;
5. 进一步评估GC012F注射液的有效性。
[Translation] Main study objectives
1. To evaluate the safety and tolerability of GC012F injection in the treatment of refractory systemic lupus erythematosus (SLE) study participants and determine the recommended dose (Recommended Phase II Dose, RP2D) of the Phase II clinical study.
Secondary study objectives
1. To further evaluate the safety of GC012F injection in the treatment of refractory SLE study participants;
2. To evaluate the effectiveness of GC012F injection in the treatment of refractory SLE study participants;
3. To evaluate the pharmacokinetic and pharmacodynamic characteristics of GC012F injection and its expansion and persistence in the study participants;
4. To evaluate the immunogenicity of GC012F injection in the study participants;
5. To further evaluate the effectiveness of GC012F injection.
GC012F注射液治疗复发/难治性多发性骨髓瘤的 I/II 期临床研究
[Translation] Phase I/II clinical study of GC012F injection in the treatment of relapsed/refractory multiple myeloma
I期研究目的:评估GC012F注射液治疗复发/难治性多发性骨髓瘤受试者的安全性与耐受性,确定II期临床研究推荐剂量(RP2D);评估GC012F注射液治疗复发/难治性多发性骨髓瘤受试者的有效性,药代动力学和药效动力学特征,免疫原性
II期研究目的:评估GC012F注射液治疗复发/难治性多发性骨髓瘤受试者的有效性;评估GC012F注射液治疗复发/难治性多发性骨髓瘤受试者的安全性,药代动力学和药效动力学特征,免疫原性
[Translation] Purpose of Phase I study: To evaluate the safety and tolerability of GC012F injection in the treatment of relapsed/refractory multiple myeloma subjects, and to determine the recommended dose (RP2D) for Phase II clinical study; to evaluate the effectiveness, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of GC012F injection in the treatment of relapsed/refractory multiple myeloma subjects
Purpose of Phase II study: To evaluate the effectiveness of GC012F injection in the treatment of relapsed/refractory multiple myeloma subjects; to evaluate the safety, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of GC012F injection in the treatment of relapsed/refractory multiple myeloma subjects
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