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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
BCMA Chimeric Antigen Receptor T Cell(SYS6020)Injection Intravenous infusion
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
Time frame: 28 days after infusion
recommended dose (RD)
recommended dose (RD)
Time frame: 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.
Time frame: 6 Months
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Time frame: 12 weeks
Proportion of participants with complete reduction of hormone dose
Proportion of participants with complete reduction of hormone dose
Time frame: 6 Months
Proportion of participants taking ≤5mg/ day of hormone
Proportion of participants taking ≤5mg/ day of hormone
Time frame: 6 Months
Proportion of participants achieving low disease activity status (LLDAS)
Proportion of participants achieving low disease activity status (LLDAS)
Time frame: 12weeks、6 Months
Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores
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Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores
Time frame: 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
Time frame: 6 Months
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Time frame: 6 Months
Change from baseline in SF-36
Change from baseline in SF-36
Time frame: 6 Months
BCMA CAR+ gene copy numberCAR gene copies
BCMA CAR+ gene copy numberCAR gene copies
Time frame: 6 Months
Number of CAR+ cells
Number of CAR+ cells
Time frame: 6 Months
Incidence of all adverse events and serious adverse events
Incidence of all adverse events and serious adverse events
Time frame: 6 Months