Refractory Active Systemic Lupus ErythematosusPhase 1NCT06694298
A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
A Phase 1 study testing SYS6020 in people with Refractory Active Systemic Lupus Erythematosus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Refractory Active Systemic Lupus Erythematosus
- What is being tested?
- SYS6020
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 26 Dec 2024to 29 Jan 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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;
About this study
Official title: 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.
- Being tested
- SYS6020
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6020Drug
Also called BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection
BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SYS6020 | Experimental | Not described Receives: Drug: SYS6020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days after infusion
recommended dose (RD)
recommended dose (RD)
Measured: 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.
Measured: 6 Months
Secondary outcomes (11)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Measured: 12 weeks
Proportion of participants with complete reduction of hormone dose
Proportion of participants with complete reduction of hormone dose
Measured: 6 Months
Proportion of participants taking ≤5mg/ day of hormone
Proportion of participants taking ≤5mg/ day of hormone
Measured: 6 Months
Proportion of participants achieving low disease activity status (LLDAS)
Proportion of participants achieving low disease activity status (LLDAS)
Measured: 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
Measured: 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
Measured: 6 Months
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Measured: 6 Months
Change from baseline in SF-36
Change from baseline in SF-36
Measured: 6 Months
BCMA CAR+ gene copy numberCAR gene copies
BCMA CAR+ gene copy numberCAR gene copies
Measured: 6 Months
Number of CAR+ cells
Number of CAR+ cells
Measured: 6 Months
Incidence of all adverse events and serious adverse events
Incidence of all adverse events and serious adverse events
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start26 Dec 2024 (estimated)
- Primary completion29 Jan 2029 (estimated)
- Study completion29 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Active Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694298
- Sponsor's protocol ID
- SYS6020-003
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study of BCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection in Refractory Active Systemic Lupus Erythematosus Patients
- ClinicalTrials.gov ID
- NCT06694298
- Acronym / sponsor ID
- SYS6020-003
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (estimated)
- Primary completion
- 29 Jan 2029 (estimated)
- Study completion
- 29 Jan 2029 (estimated)
- First posted
- 19 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group
| Arm | Type | Receives |
|---|---|---|
| SYS6020 | Experimental | Drug: SYS6020 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYS6020Also: BCMA Chimeric Antigen Receptor T Cell（SYS6020）InjectionBCMA Chimeric Antigen Receptor T Cell（SYS6020）Injection Intravenous infusion | Drug | SYS6020 |
Primary outcome
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events
Time frame: 28 days after infusion
Assess safety and tolerability of SYS6020 in patients with systemic lupus erythematosus
recommended dose (RD)
Time frame: 6 Months
recommended dose (RD)
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS).
Time frame: 6 Months
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS) at 6 months.
11 secondary outcomes
Proportion of participants who achieved systemic lupus erythematosus remission (DORIS)
Time frame: 12 weeks
Proportion of participants with complete reduction of hormone dose
Time frame: 6 Months
Proportion of participants taking ≤5mg/ day of hormone
Time frame: 6 Months
Proportion of participants achieving low disease activity status (LLDAS)
Time frame: 12weeks、6 Months
Absolute and percentage changes from baseline in SLEDA1-2K, BILAG-2004 and PGA scores
Time frame: 6 Months
Changes from baseline in antinuclear antibody, anti-ds-DNA antibody, anti-Smith antibody, C3, C4, and 24-hour urinary protein
Time frame: 6 Months
Changes of immunoglobulin (IgG, IgM, IgA, IgE) from baseline
Time frame: 6 Months
Change from baseline in SF-36
Time frame: 6 Months
BCMA CAR+ gene copy numberCAR gene copies
Time frame: 6 Months
Number of CAR+ cells
Time frame: 6 Months
Incidence of all adverse events and serious adverse events
Time frame: 6 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYS6020 in people with Refractory Active Systemic Lupus Erythematosus, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency and nature of DLT and the incidence of all adverse events and serious adverse events (time frame: 28 days after infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2024.