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This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SYS6020 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYS6020 | Drug | BCMA Chimeric Antigen Receptor T Cell(SYS6020)Injection Intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The frequency and nature of DLT and the incidence of all adverse events and serious adverse events | Assess safety and tolerability of SYS6020 in patients with systemic lupus erythematosus | 28 days after infusion |
| recommended dose (RD) | recommended dose (RD) | 6 Months |
| Proportion of participants who achieved systemic lupus erythematosus remission (DORIS). | Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) at 6 months. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) | Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) | 12 weeks |
| Proportion of participants with complete reduction of hormone dose |
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Inclusion Criteria:
Exclusion Criteria:
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Single Group
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Proportion of participants with complete reduction of hormone dose |
| 6 Months |
| Proportion of participants taking ≤5mg/ day of hormone | Proportion of participants taking ≤5mg/ day of hormone | 6 Months |
| Proportion of participants achieving low disease activity status (LLDAS) | Proportion of participants achieving low disease activity status (LLDAS) | 12weeks、6 Months |
| Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores | Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores | 6 Months |
| Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith antibody, C3, C4, and 24-hour urinary protein | Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith | 6 Months |
| Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline | Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline | 6 Months |
| Change from baseline in SF-36 | Change from baseline in SF-36 | 6 Months |
| BCMA CAR+ gene copy numberCAR gene copies | BCMA CAR+ gene copy numberCAR gene copies | 6 Months |
| Number of CAR+ cells | Number of CAR+ cells | 6 Months |
| Incidence of all adverse events and serious adverse events | Incidence of all adverse events and serious adverse events | 6 Months |