Delving into the Latest Updates on ICG318 with Synapse

Overview

Basic Info

Drug Type

CAR-T

Synonyms

Target-

Action-

Mechanism-

Therapeutic Areas

Immune System DiseasesSkin and Musculoskeletal Diseases

Active Indication

Systemic Lupus Erythematosus

Inactive Indication-

Originator Organization

Crane Precision Immunotherapy (ShenZhen) Co.,Ltd.

Active Organization

Crane Precision Immunotherapy (ShenZhen) Co.,Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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主要目的：评价ICG318 CAR-T细胞注射液在成人难治性系统性红斑狼疮（SLE）受试者中的安全性与耐受性。次要目的：初步评价ICG318 CAR-T细胞注射液治疗成人难治性SLE受试者的有效性；评价ICG318 CAR-T细胞注射液的药代动力学（PK）、药效动力学（PD）特征和免疫原性。

[Translation]

Primary objective: To evaluate the safety and tolerability of ICG318 CAR-T cell injection in adult subjects with refractory systemic lupus erythematosus (SLE). Secondary objective: To preliminarily evaluate the efficacy of ICG318 CAR-T cell injection in the treatment of adult subjects with refractory SLE; To evaluate the pharmacokinetic (PK), pharmacodynamic (PD) characteristics and immunogenicity of ICG318 CAR-T cell injection.

Start Date-

Sponsor / Collaborator