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Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评估IM19 CAR-T细胞治疗复发或难治CD19阳性急性B淋巴细胞白血病的安全性和有效性的I/II期临床研究
[Translation] Phase I/II clinical study evaluating the safety and efficacy of IM19 CAR-T cells in the treatment of relapsed or refractory CD19-positive acute B lymphocytic leukemia
I期阶段的主要目的为评估IM19 CAR-T细胞治疗3-25岁CD19阳性复发或难治的急性B淋巴细胞白血病患者的安全性、耐受性以及药代动力学特征,并确定推荐的Ⅱ期治疗剂量;II期阶段的主要目的为评估IM19 CAR-T细胞治疗3-25岁CD19 阳性复发或难治的急性B淋巴细胞白血病患者的疗效。
[Translation] The main purpose of Phase I is to evaluate the safety, tolerability and pharmacokinetic characteristics of IM19 CAR-T cells in the treatment of CD19-positive relapsed or refractory acute B lymphoblastic leukemia patients aged 3-25 years, and to determine the recommended II The main purpose of Phase II is to evaluate the efficacy of IM19 CAR-T cells in the treatment of CD19-positive relapsed or refractory acute B lymphocytic leukemia patients aged 3-25 years.
评估IM19 CAR-T细胞治疗复发或难治CD19阳性套细胞淋巴瘤患者的安全性和有效性的I/II期临床研究
[Translation] Phase I/II clinical study evaluating the safety and efficacy of IM19 CAR-T cells in patients with relapsed or refractory CD19-positive mantle cell lymphoma
主要目的:评估IM19 CAR-T细胞治疗复发或难治CD19 阳性套细胞淋巴瘤患者的安全性和疗效。
次要目的:评估IM19 CAR-T细胞治疗复发或难治的CD19阳性套细胞淋巴瘤患者的除90天ORR外的其它疗效指标、药代动力学特征及免疫原性。
[Translation] Main objective: To evaluate the safety and efficacy of IM19 CAR-T cell therapy in patients with relapsed or refractory CD19-positive mantle cell lymphoma.
Secondary objectives: To evaluate other efficacy indicators, pharmacokinetics and immunogenicity in addition to 90-day ORR in patients with relapsed or refractory CD19-positive mantle cell lymphoma treated with IM19 CAR-T cells.
评估 IM19CAR-T 细胞治疗复发或难治 CD19 阳性侵袭性非霍奇金淋巴瘤患者的安全性和有效性的 I/II 期临床研究
[Translation] Phase I/II clinical study evaluating the safety and efficacy of IM19CAR-T cells in patients with relapsed or refractory CD19-positive aggressive non-Hodgkin lymphoma
I期阶段的主要目的为评估IM19 CAR-T细胞治疗复发或难治CD19 阳性侵袭性非霍奇金淋巴瘤患者的安全性; II期阶段的主要目的为评估IM19 CAR-T细胞治疗复发或难治CD19阳性侵袭性非霍奇金淋巴瘤患者的疗效。
[Translation] The main purpose of Phase I is to evaluate the safety of IM19 CAR-T cells in the treatment of patients with relapsed or refractory CD19-positive aggressive non-Hodgkin lymphoma; the main purpose of Phase II is to evaluate the safety of IM19 CAR-T cells in the treatment of relapsed or refractory Efficacy in the treatment of CD19-positive aggressive non-Hodgkin lymphoma patients.
100 Clinical Results associated with Beijing Yimiao Medical Technology Co Ltd
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100 Deals associated with Beijing Yimiao Medical Technology Co Ltd
100 Translational Medicine associated with Beijing Yimiao Medical Technology Co Ltd