A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

NCT06694298 | Not Yet Recruiting Phase 1

• 1 other identifier: SYS6020-003
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Refractory Active Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)

  12 weeks

• Proportion of participants with complete reduction of hormone dose

  6 Months

• Proportion of participants taking ≤5mg/ day of hormone

  6 Months

• 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

  6 Months

Study Arms (1)

SYS6020

EXPERIMENTAL

Drug: SYS6020

Interventions

SYS6020 DRUG

BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection Intravenous infusion

Also known as: BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection

SYS6020

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years old, ≤70 years old;
• \. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
• \. 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.
• \. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
• \. SLEDAI-2K score≥7.
• \. 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
• \. PGA \> 1.0;

You may not qualify if:

• \. Severe lupus nephritis within 8 weeks before screening;
• \. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
• \. uncontrolled lupus crisis within 8 weeks before screening;
• \. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
• \. vasculitis or inflammatory arthritis or skin disease other than SLE or at screening;
• \. complicated with other autoimmune diseases;
• \. A B-cell-targeting agent have been used or is planned to be used within 8 weeks before screening，
• \. received Renal Replacement Therapy（RRT）within 3 months before the screening period or anticipates the need for RRT during the study period;
• \. 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;
• \. participants with a known allergy, hypersensitivity, intolerance, or contraindications to SYS6020 or any component of the drugs that may be used in the study,
• \. active bacterial, fungal, or viral infection within 2 weeks before apheresis;

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 19, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): January 29, 2029
• Study Completion (Estimated): January 29, 2029
• Last Updated: November 19, 2024

Record last verified: 2024-11