Clinical Study of GC012F Injection in Subjects with Refractory Systemic Lupus Erythematous
| Title | Clinical Study of GC012F Injection in Subjects with Refractory Systemic Lupus Erythematous |
|---|---|
| Description | This is a single-arm, non-randomized and open-label clinical study to evaluate the safety of GC012F Injection in patients with refractory systemic lupus erythematosus (SLE) and determine the recommended phase II dose (RP2D). This study will be divided into screening, apheresis, baseline, lymphodepletion, infusion, and follow-up. Eligible subjects will receive the apheresis and then infusion after the production of CAR-T product. Subjects will be followed up for safety and efficacy after GC012F infusion. qPCR method was used to detect the expansion of cells in vivo of subjects after CAR-T infusion. |
| Organism | Homo sapiens |
| Data Type | Genetic Biomarkers |
| Data Accessibility | Controlled-access |
| BioProject | PRJCA025162 |
| Release Date | 2024-04-12 |
| Submitter | siyu huang (siyu.huang@gracellbio.com) |
| Organization | Gracell Biotechnologies (Shanghai) Co., Ltd. |
| Submission Date | 2024-04-10 |
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| File ID | File Title | Number/Samples | File Type | File Size | File Suffix | Download Times | Download |
|---|---|---|---|---|---|---|---|
| OMIX006208-02 | SLE IIT | 2 | Genetic Biomarkers | 1.8 MB | zip | 0 | Controlled |