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A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus

ConditionRefractory Active Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • SYS6020

    Drug

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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: SYS6020Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
2

recommended dose (RD)

recommended dose (RD)

Time frame
6 Months
3

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

Secondary outcomes

1

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

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

Time frame
12 weeks
2

Proportion of participants with complete reduction of hormone dose

Proportion of participants with complete reduction of hormone dose

Time frame
6 Months
3

Proportion of participants taking ≤5mg/ day of hormone

Proportion of participants taking ≤5mg/ day of hormone

Time frame
6 Months
4

Proportion of participants achieving low disease activity status (LLDAS)

Proportion of participants achieving low disease activity status (LLDAS)

Time frame
12weeks、6 Months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: