Clinical trial NCT06694298: A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
Official title: A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Refractory Active Systemic Lupus Erythematosus
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18 years old, ≤70 years old;
* 2. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
* 3. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
* 4. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
* 5. SLEDAI-2K score≥7.
* 6. BILAG2004 meets one of the following two criteria:a）BILAG grade A is defined as ≥1 organ system；b）BILAG grade B is defined as ≥2 organ systems
* 7. PGA \> 1.0;

Exclusion Criteria:

* 1. Severe lupus nephritis within 8 weeks before screening;
* 2. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
* 3. uncontrolled lupus crisis within 8 weeks before screening;
* 4. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
* 5. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
* 6. complicated with other autoimmune diseases;
* 7. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
* 8. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
* 9. participants who will undergo major surgery or invasive intervention within 4 weeks prior to apheresis or plan for systemic or local tumor resection during the study period;
* 10. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,
* 11. active bacterial, fungal, or viral infection within 2 weeks before apheresis;

Primary outcomes:
measure: The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
timeFrame: 28 days after infusion
measure: recommended dose (RD)
timeFrame: 6 Months
measure: Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).
timeFrame: 6 Months
Secondary outcomes:
measure: Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
timeFrame: 12 weeks
measure: Proportion of participants with complete reduction of hormone dose
timeFrame: 6 Months
measure: Proportion of participants taking ≤5mg/ day of hormone
timeFrame: 6 Months
measure: Proportion of participants achieving low disease activity status (LLDAS)
timeFrame: 12weeks、6 Months
measure: Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores
timeFrame: 6 Months
measure: Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith antibody, C3, C4, and 24-hour urinary protein
timeFrame: 6 Months
measure: Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
timeFrame: 6 Months
measure: Change from baseline in SF-36
timeFrame: 6 Months
measure: BCMA CAR+ gene copy numberCAR gene copies
timeFrame: 6 Months
measure: Number of CAR+ cells
timeFrame: 6 Months
measure: Incidence of all adverse events and serious adverse events
timeFrame: 6 Months
Other outcomes:
Locations:
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