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GCK-01细胞注射液联合利妥昔单抗治疗复发或难治性滤泡性淋巴瘤的安全性和耐受性的I期临床研究
[Translation] A phase I clinical study on the safety and tolerability of GCK-01 cell injection combined with rituximab in the treatment of relapsed or refractory follicular lymphoma
主要目的:评价GCK-01细胞注射液在R/R FL患者中的安全性和耐受性。 初步确定GCK-01细胞注射液的最大耐受剂量(MTD)或II期临床推荐剂量(RP2D)。
次要目的:评估GCK-01细胞注射液在体内的药代动力学(PK)和药效动力学(PD)或其他生物标志物特征。初步评估GCK-01细胞注射液联合利妥昔单抗治疗R/R FL患者的有效性。
[Translation] Primary Objective: To evaluate the safety and tolerability of GCK-01 cell injection in patients with R/R FL. To preliminarily determine the maximum tolerated dose (MTD) or recommended Phase II dose (RP2D) of GCK-01 cell injection.
Secondary Objective: To evaluate the in vivo pharmacokinetics (PK) and pharmacodynamics (PD) of GCK-01 cell injection, or other biomarker characteristics. To preliminarily evaluate the efficacy of GCK-01 cell injection combined with rituximab in patients with R/R FL.
100 Clinical Results associated with Shanghai Jingshan Biotechnology Co., Ltd.
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100 Translational Medicine associated with Shanghai Jingshan Biotechnology Co., Ltd.