drugset / Trial / NCT06340490
A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)
Phase 1
Not yet recruiting
24 enrolled
Guangdong Ruishun Biotech Co., Ltd
Changhai Hospital · collabPeking University People's Hospital · collabRenJi Hospital · collabThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collab
NaSingle-groupOpen-labelTreatment
Summary
This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.
Timeline
- Start
- 2024-05-15
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | RJMty19 | Cell therapy | 5e+06 cells/kg | — |
| Subject | RJMty19 | Cell therapy | 1e+07 cells/kg | — |
| Subject | RJMty19 | Cell therapy | 2e+07 cells/kg | — |