A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

Phase 1

Not yet recruiting

• Conditions: Refractory Active Systemic Lupus Erythematosus
• Interventions: Drug: SYS6020

• Registration Number: NCT06694298
• Lead Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-17
• Last Update Submitted: 2024-11-17
• Study First Posted: 2024-11-19
• Last Update Posted: 2024-11-19
• Study Start: 2024-12-26
• Primary Completion: 2029-01-29
• Study Completion: 2029-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYS6020	SYS6020	-

Primary Outcome Measures

Name	Time	Method
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events	28 days after infusion	Assess safety and tolerability of SYS6020 in patients with systemic lupus erythematosus
recommended dose (RD)	6 Months	recommended dose (RD)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).	6 Months	Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) at 6 months.

Secondary Outcome Measures

Name	Time	Method
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)	12 weeks	Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Proportion of participants with complete reduction of hormone dose	6 Months	Proportion of participants with complete reduction of hormone dose
Proportion of participants taking ≤5mg/ day of hormone	6 Months	Proportion of participants taking ≤5mg/ day of hormone
Proportion of participants achieving low disease activity status (LLDAS)	12weeks、6 Months	Proportion of participants achieving low disease activity status (LLDAS)
Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores	6 Months	Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores
Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith antibody, C3, C4, and 24-hour urinary protein	6 Months	Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline	6 Months	Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Change from baseline in SF-36	6 Months	Change from baseline in SF-36
BCMA CAR+ gene copy numberCAR gene copies	6 Months	BCMA CAR+ gene copy numberCAR gene copies
Number of CAR+ cells	6 Months	Number of CAR+ cells
Incidence of all adverse events and serious adverse events	6 Months	Incidence of all adverse events and serious adverse events