Systemic Lupus ErythematosusNCT07104344
Study of CM355 in Patients With Systemic Lupus Erythematosus
A study testing CM355 in people with Systemic Lupus Erythematosus, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- CM355
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 1 Sep 2027
- Phase
- Interventional
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);
- Age ≥ 18 to ≤ 65 years old, male or female;
- At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)/ American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；
- systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and/or anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and/or anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；
- Definition of refractory SLE;
- The treatment regimen for SLE was stable for more than 4 weeks before the first dose.
Who cannot join
- Renal disease: patients with severe lupus nephritis;
- Patients with central nervous system diseases;
- Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;
- Any other condition assessed by investigator as unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Single-arm Clinical Study to Observe the Safety and Efficacy of CM355 in the Treatment of Refractory Systemic Lupus Erythematosus
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
Read the detailed description
This study is designed to investigate the safety and efficacy of CM355 in patients with moderately to severely active SLE who are refractory to treatment, and to analyze its pharmacokinetic profile , pharmacodynamic effects, and immunogenicity.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- CM355
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CM355Biological
CM355 injection
| Study group | Role | What they receive |
|---|---|---|
| CM355 | Experimental | Not described Receives: Biological: CM355 |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse events (AE)
Incidence and severity of adverse events (AE)
Measured: Throughout the study，an average of about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start25 Sep 2025
- Primary completion15 Jun 2026
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-arm, open-label study will enrol five patients with SLE. All participants will receive CM355 in addition to standard treatment. The first two participants will receive step-up doses of 0·1 mg on day 1, 0·3 mg on day 8, and 0·9 mg on day 15. After 21 days of observation following the third dose, and provided no dose-limiting toxicity (DLT) has occurred, the subsequent three participants will receive 0·3 mg on day 1, 0·9 mg on day 8, and 2·7 mg on day 15. The study comprises a screening period of up to 4 weeks, a treatment period, and a primary follow-up period extending to 24 weeks after the final dose. Following completion of the primary study period, participants enter an extended follow-up phase of 1-2 years, with their informed consent, to assess the durability of clinical responses and long-term safety. No further administration of the investigational product is planned during this extended follow-up period.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hai Long, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104344
- Sponsor's protocol ID
- CM355_SLE_IIT
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Single-arm Clinical Study to Observe the Safety and Efficacy of CM355 in the Treatment of Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07104344
- Acronym / sponsor ID
- CM355_SLE_IIT
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Aug 2025 (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 was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
Detailed description
This study is designed to investigate the safety and efficacy of CM355 in patients with moderately to severely active SLE who are refractory to treatment, and to analyze its pharmacokinetic profile , pharmacodynamic effects, and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm, open-label study will enrol five patients with SLE. All participants will receive CM355 in addition to standard treatment. The first two participants will receive step-up doses of 0·1 mg on day 1, 0·3 mg on day 8, and 0·9 mg on day 15. After 21 days of observation following the third dose, and provided no dose-limiting toxicity (DLT) has occurred, the subsequent three participants will receive 0·3 mg on day 1, 0·9 mg on day 8, and 2·7 mg on day 15. The study comprises a screening period of up to 4 weeks, a treatment period, and a primary follow-up period extending to 24 weeks after the final dose. Following completion of the primary study period, participants enter an extended follow-up phase of 1-2 years, with their informed consent, to assess the durability of clinical responses and long-term safety. No further administration of the investigational product is planned during this extended follow-up period.
| Arm | Type | Receives |
|---|---|---|
| CM355 | Experimental | Biological: CM355 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);
- Age ≥ 18 to ≤ 65 years old, male or female;
- At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)/ American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；
- systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and/or anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and/or anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；
- Definition of refractory SLE;
Key exclusion criteria (4 listed)
- Renal disease: patients with severe lupus nephritis;
- Patients with central nervous system diseases;
- Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;
- Any other condition assessed by investigator as unsuitable for participation in the study.
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 |
|---|---|---|
| CM355CM355 injection | Biological | CM355 |
Primary outcome
adverse events (AE)
Time frame: Throughout the study，an average of about 1 year
Incidence and severity of adverse events (AE)
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 Oct 2026.
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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. This study is not recruiting at the moment.
Hai Long principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CM355 in people with Systemic Lupus Erythematosus, run by Second Xiangya Hospital of Central South University at 1 site in China.
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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
adverse events (AE) (time frame: Throughout the study，an average of about 1 year). 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 Oct 2026.