[Translation] Phase I Clinical Trial of Denorensai Injection (or RC19D2 Cell Injection) in the Treatment of CD19-Positive Relapsed or Refractory Diffuse Large B-Cell Lymphoma
主要目的:评价RC19D2细胞注射液治疗CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者的安全性和耐受性;确定Ⅱ期临床试验的推荐给药剂量(RP2D)。次要目的:评价RC19D2细胞注射液治疗CD19阳性的复发或难治性弥漫大B细胞淋巴瘤的初步疗效;评价RC19D2细胞注射液在CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者中的细胞代谢动力学;评价RC19D2细胞注射液在CD19阳性的复发或难治性弥漫大B细胞淋巴瘤患者中的药效动力学;评价RC19D2细胞注射液的免疫原性。
[Translation] Main purpose: To evaluate the safety and tolerability of RC19D2 cell injection in the treatment of patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to determine the recommended dosage (RP2D) for phase II clinical trials. Secondary objectives: To evaluate the preliminary efficacy of RC19D2 cell injection in the treatment of CD19-positive relapsed or refractory diffuse large B-cell lymphoma; to evaluate the efficacy of RC19D2 cell injection in patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma The metabolic kinetics of RC19D2 cells; evaluate the pharmacodynamics of RC19D2 cell injection in patients with CD19-positive relapsed or refractory diffuse large B-cell lymphoma; evaluate the immunogenicity of RC19D2 cell injection.