drugset / Trial / NCT05765006
CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
Timeline
- Start
- 2023-02-24
- Primary completion
- 2024-12-30
- Completion
- 2025-12-30
Publications
- Results Kaufman JL, Deak ST, Erdman W. Radionuclide scans to define patterns of occult myonecrosis. N J Med. 1986 Feb;83(2):101-3. No abstract available.
- Shu J, Xie W, Mei C, Ren A, Ke S, Ma M, Zhou Z, Hu Y, Mei H. Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial. EClinicalMedicine. 2025 Apr 30;83:103229. doi: 10.1016/j.eclinm.2025.103229. eCollection 2025 May.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Relmacabtagene Autoleucel | Cell therapy | 2.5e+07 cells | — |
| Subject | Relmacabtagene Autoleucel | Cell therapy | 5e+07 cells | — |
| Subject | Relmacabtagene Autoleucel | Cell therapy | 1e+08 cells | — |
| Subject | Relmacabtagene Autoleucel | Cell therapy | 1.5e+08 cells | — |