drugset / Trial / NCT06373991
A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
Phase 1
Not yet recruiting
12 enrolled
EdiGene Inc.
Changping Laboratory · collabThe First Affiliated Hospital of Henan University of Science and Technology · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-07-24
- Primary completion
- 2027-04-30
- Completion
- 2027-04-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ATHENA CAR-T | Cell therapy | — | — |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Fludarabine | Small molecule | — | Intravenous |