|
|
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
|
|
|
Inactive Indication- |
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
|
MechanismCLDN18.2 inhibitors |
|
|
|
Inactive Indication- |
Drug Highest PhaseIND Approval |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项评估HD CD19 CAR-T治疗难治或复发的B细胞急性淋巴细胞白血病患者的I/II期安全性和有效性的临床试验
[Translation] A Phase I/II clinical trial evaluating the safety and efficacy of HD CD19 CAR-T in patients with refractory or relapsed B-cell acute lymphoblastic leukemia
第一阶段:
主要目的:
主要目的:评价HD CD19 CAR-T细胞治疗r/r B-ALL患者的安全性和耐受性,并确定MTD或RP2D。
次要目的和终点:
1)评估HD CD19 CAR-T细胞在体内的药代动力学(PK)特征
2)初步评估HD CD19 CAR-T细胞治疗r/r B-ALL的有效性
探索性目的:
1)探索性研究HD CD19 CAR-T的免疫原性
2)探索性研究HD CD19 CAR-T细胞在体内的药效动力学(PD)特征
第二阶段:
主要目的:
主要目的:进一步确证HD CD19 CAR-T细胞治疗成人r/r B-ALL患者的有效性。
次要目的:评价HD CD19 CAR-T的安全性与有效性、药代动力学及药效动力学特征。
探索性目的
1)探索性分析基线与CAR-T的疗效、安全性、PK的相关性。
2)探索性分析CAR结构基因组插入位点。
[Translation] Phase I:
Main objective:
Main objective: To evaluate the safety and tolerability of HD CD19 CAR-T cells in the treatment of r/r B-ALL patients and determine the MTD or RP2D.
Secondary objectives and endpoints:
1) Evaluate the pharmacokinetic (PK) characteristics of HD CD19 CAR-T cells in vivo
2) Preliminary evaluation of the effectiveness of HD CD19 CAR-T cells in the treatment of r/r B-ALL
Exploratory objectives:
1) Exploratory study of the immunogenicity of HD CD19 CAR-T
2) Exploratory study of the pharmacodynamic (PD) characteristics of HD CD19 CAR-T cells in vivo
Phase II:
Main objective:
Main objective: To further confirm the effectiveness of HD CD19 CAR-T cells in the treatment of adult r/r B-ALL patients.
Secondary objectives: To evaluate the safety and efficacy, pharmacokinetic and pharmacodynamic characteristics of HD CD19 CAR-T.
Exploratory objectives
1) Exploratory analysis of the correlation between baseline and CAR-T efficacy, safety, and PK.
2) Exploratory analysis of CAR structural genome insertion sites.
HD CD19 CAR-T治疗难治或复发的侵袭性B细胞非霍奇金淋巴瘤患者的Ib/II期确证性临床试验
[Translation] Phase Ib/II confirmatory clinical trial of HD CD19 CAR-T in patients with refractory or relapsed aggressive B-cell non-Hodgkin's lymphoma
第一阶段(Ⅰb期):评估HD CD19 CAR-T在临床推荐剂量4×106 CAR+ cells/kg治疗目标适应症的安全性
第二阶段(Ⅱ期):评估HD CD19 CAR-T细胞治疗r/r B-NHL患者的有效性
[Translation] Phase I (Phase Ib): Evaluate the safety of HD CD19 CAR-T at the clinically recommended dose of 4×106 CAR+ cells/kg for the treatment of target indications
Phase II (Phase II): Evaluate the effectiveness of HD CD19 CAR-T cells in the treatment of r/r B-NHL patients
/ Unknown statusEarly Phase 1IIT A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer
The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
100 Clinical Results associated with Huadao (Shanghai) Biomedical Co., Ltd.
0 Patents (Medical) associated with Huadao (Shanghai) Biomedical Co., Ltd.
100 Deals associated with Huadao (Shanghai) Biomedical Co., Ltd.
100 Translational Medicine associated with Huadao (Shanghai) Biomedical Co., Ltd.