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Clinical Trials associated with SENL-103 / Not yet recruitingPhase 1IIT An open-label, single-arm Phase I clinical study of SENL103 autologous T-cell injection (S103) for the treatment of refractory generalized myasthenia gravis
Start Date07 Nov 2025 |
Sponsor / Collaborator- |
/ Unknown statusEarly Phase 1 Clinical Study on the Safety and Efficacy of SENL103 Autologous T Cell Injection in the Treatment of Recurrent or Refractory Plasma Cell Blood Tumors
To observe the safety and efficacy of SENL103 cells in the treatment of patients with recurrent or refractory plasma cell blood tumors.
/ Not yet recruitingPhase 1 SENL103自体T细胞注射液(S103)治疗难治性全身型重症肌无力的开放、单臂的I期临床研究
[Translation] An open, single-arm Phase I clinical study of SENL103 autologous T cell injection (S103) in the treatment of refractory generalized myasthenia gravis
第一阶段:
主要目的:1、评估 S103 治疗难治性全身型重症肌无力的安全性、耐受性
2、确定最大耐受剂量(MTD)或Ⅱ期推荐剂量(RP2D)
次要目的:1、评价 S103 治疗难治性全身型重症肌无力的疗效及长期不良反应
2、评价 S103 治疗难治性全身型重症肌无力的药代动力学特征
第二阶段:
主要目的:初步评价 S103 在难治性全身型重症肌无力研究参与者中的有效性
次要目的:1、初步评价 S103 治疗难治性全身型重症肌无力的安全性和长期不良反应
2、评价 S103 治疗难治性全身型重症肌无力的药代动力学特征
[Translation] Phase I:
Primary Objectives: 1. Evaluate the safety and tolerability of S103 in the treatment of refractory generalized myasthenia gravis
2. Determine the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D)
Secondary Objectives: 1. Evaluate the efficacy and long-term adverse reactions of S103 in the treatment of refractory generalized myasthenia gravis
2. Evaluate the pharmacokinetic characteristics of S103 in the treatment of refractory generalized myasthenia gravis
Phase II:
Primary Objective: Preliminary evaluation of the efficacy of S103 in study participants with refractory generalized myasthenia gravis
Secondary Objectives: 1. Preliminary evaluation of the safety and long-term adverse reactions of S103 in the treatment of refractory generalized myasthenia gravis
2. Evaluate the pharmacokinetic characteristics of S103 in the treatment of refractory generalized myasthenia gravis
100 Clinical Results associated with SENL-103
100 Translational Medicine associated with SENL-103
100 Patents (Medical) associated with SENL-103
100 Deals associated with SENL-103