A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients

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 Overview

• Status: Not yet recruiting
• Conditions: Refractory Active Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: SYS6020

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYS6020	Drug: SYS6020; BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection Intravenous infusion; Other Names: BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2024
• Primary Completion (Estimated): January 29, 2029
• Study Completion (Estimated): January 29, 2029

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 17, 2024
• First Posted (Estimated): November 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 17, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: SYS6020-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No