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A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus

Lupus Erythematosus, Systemic Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus

Clinical Trial Summary

The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is: • To evaluate the safety and tolerability of ATHENA CAR-T. After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.

Clinical Trial Description

This study is a single center, one-arm, open label, phase I study aimed at evaluate the safety and effectiveness of ATHENA CAR-T treating moderate to severe SLE patients. A traditional "3+3" design is used with two doses. DLT is monitored. Safety and effectiveness are followed up until 24 months post infusion of ATHENA CAR-T. Besides safety monitoring, efficacy is evaluated via SLEDAI-2000, BILAG-2004, PGA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06373991
Study type Interventional
Source EdiGene Inc.
Contact Chao Liu
Phone (86)-10-80733899
Email cliu@edigene.com
Status Not yet recruiting
Phase Phase 1
Start date July 24, 2024
Completion date April 30, 2027
View Details
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