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Clinical Trials associated with HR-003评估抗人BCMA T细胞注射液在复发/难治性多发性骨髓瘤受试者中的有效性和安全性的Ⅱ期临床研究
[Translation] Phase II clinical study to evaluate the efficacy and safety of anti-human BCMA T cell injection in subjects with relapsed/refractory multiple myeloma
主要研究目的:评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的有效性。
次要研究目的:
(1)评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的安全性。
(2)评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的药代动力学。
(3)评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的药效动力学。
(4)评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的免疫原性。
(5)评价抗人BCMA T细胞注射液用于治疗复发/难治性多发性骨髓瘤受试者的其他有效性指标。
探索性研究目的:
(1)探索抗人BCMA T细胞回输后在受试者体内的分布及在外周血中免疫表型的变化;
(2)探索胸腔积液、腹腔积液、脑脊液等中的药效动力学指标;
(3)探索抗人BCMA T细胞回输后血清脏器损伤指标及氧还状态。
[Translation] Primary study objectives: To evaluate the efficacy of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
Secondary study objectives:
(1) To evaluate the safety of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
(2) To evaluate the pharmacokinetics of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
(3) To evaluate the pharmacodynamics of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
(4) To evaluate the immunogenicity of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
(5) To evaluate other efficacy indicators of anti-human BCMA T cell injection in the treatment of relapsed/refractory multiple myeloma subjects.
Exploratory study objectives:
(1) To explore the distribution of anti-human BCMA T cells in the subjects and the changes in the immune phenotype in the peripheral blood after reinfusion;
(2) To explore the pharmacodynamic indicators in pleural effusion, peritoneal effusion, cerebrospinal fluid, etc.;
(3) To explore the serum organ damage indicators and redox status after reinfusion of anti-human BCMA T cells.
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection Therapy for Relapsed/Refractory Multiple Myeloma
A Phase Ⅱ Clinical Study Evaluating the Efficacy and Safety of Human BCMA Targeted T Cells Injection(BCMA CAR-T) Therapy for R/R MM.
Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of BCMA CAR+ T cells.
/ Active, not recruitingEarly Phase 1 A Early Phase 1 Clinical Trial to Evaluate the Safety and Efficacy of Human Derived Anti-BCMA CAR-T Injection for Subjects with Relapsed/Refractory Multiple Myeloma
This study is a single-arm, open-label, dose-escalation trial to explore the safety, tolerability and pharmacokinetic/pharmacodynamics characteristics of Human Derived anti-BCMA CAR-T Injection , and to preliminarily observe the efficacy of the trial drug in patients with relapsed/refractory multiple myeloma.
100 Clinical Results associated with HR-003
100 Translational Medicine associated with HR-003
100 Patents (Medical) associated with HR-003
100 Deals associated with HR-003