Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06373991
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-04-09
Brief Title:
A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
Sponsor:
EdiGene Inc
Organization:
EdiGene Inc
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 33 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
A traditional 33 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None