Systemic Lupus Erthematosus (SLE)Phase 1CLEARNCT07358988
KN5501 Cell Injection for Refractory SLE(CLEAR)
A Phase 1 study testing KN5501 cell injection in people with Systemic Lupus Erthematosus (SLE), run by Ruitherapeutics Co., LTD at 6 sites in China.
Trial summary
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE)
- What is being tested?
- KN5501 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesChina
- Study dates
- Jan 2026to Jul 2027
- 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. Aged 18~70(including thresholds) when obtaining informed consent;
- 2. Body weight > 40.0 kg at screening;
- 3. Refractory SLE patients with moderate to severe activity;
- 4. CBC meeting predefined requirements at screening, including ANC ≥ 1.5×10^9/L, Hb ≥ 80g/L, and PLT ≥ 50×10^9/L(Not applicable, if it is ITP due to active SLE disease which is judged by investigator);
- 5. Adequate liver, kidney, lung and ;heart function at screening;
- 6. The date of last supportive therapy of hemopoietic growth factor(including EPO, G-CSF, GM-CSF and TPO, etc.)should be at least 2 weeks before screening visit, the last date of PLT infusion should be at least one week before screening visit, and the last date of RBC infusion should be at least 2 weeks before screening visit;
- 7. The number of CD19+ B cells in peripheral blood > 5 cells per microliter at screening;
- 8. Negative serum pregnancy test for WOCBPs at screening. Male or Female trial participants of child bearing potential should utilize efficient contraceptive measures from ICF signing until at least one year since the last dose, and promise not to donate ovums or sperms until at least one year since the last dose.
Who cannot join
- 1. Hypersensitive or allergic to any components of KN5501(e.g. DEXTRAN 40) or other trial interventions including fludarabine, cyclophosphamide, and tocilizumab, or having ever experienced severe anaphylaxis;
- 2. Severe lupus nephritis patients, defined as proteinuria ≥3.5g/24h or a history of renal replacement therapy. Or high risk of progressive LN disease which will probably require induced intensive treatment;
- 3. CNS affected, including but not limited to lupus encephalopathy, seizure, strock(ischemic or hemorrhagic), dementia, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or mental disease;
- 4. Severe lung disease, e.g. pulmonary hypertension ≥ grade 3(WHO), or requiring mask oxygen therapy or ventilator-assisted breathing(non-invasive or invasive) ;
- 5. Unstable cardiovascular system, e.g. myocardial infarction within 6 months before screening, unstable angina within 3 months before screening, uncontrolled and clinically significant ventricular arrhythmia(including ventricular tachycardia, ventricular fibrillation, or TdP), second-degree atrioventricular block of Mobitz type II or third-degree atrioventricular block, congestive heart failure with New York Heart Association class ≥ 3; poorly controlled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg), or accompanied by hypertensive crisis or hypertensive encephalopathy;
- 6. Malignancy within 5 years before screening, excluding tumors with negligible risk of metastasis or death that are curable, such as radically treated non-melanoma skin cancer, localized prostate cancer, biopsy-confirmed cervical carcinoma in situ or squamous intraepithelial lesions detected by cervical smears, and completely resected ductal carcinoma in situ of the breast;
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- 7. Severe infections requiring intravenous anti-infection treatment within 14 days before planned lymphodepletion, however preventive therapy is permitted;
- 8. Active or latent tuberculosis at screening;
- 9. HBV or HCV infection at screening. If positve HBsAg and/or HBcAb, HBV-DNA should be tested to confirm. If positive HCV-Ab, HCV-RNA should be tested to confirm;
- 10. Active HIV infection history, or positive serum HIV antigen or antibody test, or positive antibody test for Treponema Pallidum at screening.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Director of Rheumatology Department, +86 139 1178 8572, mengtao.li@cstar.org.cn
Bengbu Medical College First Affiliated Hospital
Bengbu, Anhui
Director of Rheumatology Department, +86 15255227208, uglboy2002@126.com
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan
Director of Rheumatology Department, +86 13663884080, sxf64817332@163.com
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu
Director of Rheumatology Department, +86 13770769608, tanwenfeng2005@126.com
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality
Director of Rheumatology Department, +86 15921061312, dongbaozhao@163.com
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Director of Rheumatology Department, +86 13995671635, liqiubai_hust@hust.edu.cn
About this study
Official title: A Multicenter Phase I Clinical Study of CD19-Targeted CAR-NK Cell Therapy for Moderate to Severe Active Systemic Lupus Erythematosus in China
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are:
- Is KN5501 cell injection safe in adults with SLE? And the maximum tolerated dose?
- Does KN5501 cell injection lower the disease activity of SLE in adults with refractory SLE？
Read more
Participants will:
Receive one or multiple (3 to 5 times) intravenous infusion of KN5501 cell injection at inpatient ward after lymphodepletion.
Visit the clinic at predefined frequency (from 1 week interval to 12-16 weeks' interval) for checkups and tests.
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Being tested
- KN5501 cell injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN5501 cell injectionDrug
In Part 1(SAD), six different doses will be explored to establish maximum tolerated dose for single-dose setting; In part 2(MAD and expansion), about 2-4 multiple-dose dosing regimen will be explored, and cohorts of 1-2 dosing regimen will be selected to expand.
| Study group | Role | What they receive |
|---|---|---|
| KN5501 cell injection | Experimental | inter-patient dose escalation arm with six dose levels for single-dose setting and 2-4 dose levels for multiple-dose setting Receives: Drug: KN5501 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: from the first dose to 2 weeks (SAD) or 4 weeks (MAD)
Number of participants with adverse events
Number of participants with adverse events(including abnormal physical examinations(PE), abnormal vital signs, abnormal laboratory test results and abnormal 12-ECG readings
Measured: from enrollment to the last assessment at 52 weeks
Secondary outcomes (11)
Time to Peak Plasma Concentration (Tmax)
Measured: from the first dose to 4 weeks.
Peak Plasma Concentration (Cmax)
Measured: from the first dose to 4 weeks
Area under the plasma concentration versus time curve (AUC)
Measured: from the first dose to 4 weeks.
Duration of retention
Measured: from the first dose to 4 weeks
Number of CD19+ B cells per microlitre in peripheral blood (PD biomarker)
Measured: from enrollment to the last assessment at 52 weeks
Concentration of cytokines (IL-6, etc.) in peripheral blood (PD biomarker)
Measured: from enrollment to the last assessment at 52 weeks
Concentration of immunoglobulins (IgG, IgM, IgE and IgA) in peripheral blood (PD biomarker)
Measured: from enrollment to the last assessment at 52 weeks
Concentration of serum complements (PD biomarker)
Measured: from enrollment to the last assessment at 52 weeks
Number or percentage of B cell subsets in peripheral blood (PD biomarker)
Measured: from enrollment to the last assessment at 52 weeks
Response rate of DORIS 2021(The 2021 Definitions Of Remission In SLE)
Measured: from enrollment to the last assessment at 52 weeks
Response rate of LLDAS (Lupus Low Disease Activity Status)
Measured: from enrollment to the last assessment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 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 Erthematosus (SLE)Studies 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
- Sequential
- Model description
- Part 1(SAD)：establish Maximum Tolerated Dose for single-dose setting, and dosing regimen for MAD; Part 2(MAD and expansion): establish Recommended Phase 2 Dose(RP2D)
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruitherapeutics Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mengtao Li, Principal investigator, Rheumatology Department, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358988
- Sponsor's protocol ID
- RUI-KN5501-SIL01
- Acronym
- CLEAR
- Status last verified
- Jan 2026
- First submitted
- 1 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Clinical Study of CD19-Targeted CAR-NK Cell Therapy for Moderate to Severe Active Systemic Lupus Erythematosus in China
- ClinicalTrials.gov ID
- NCT07358988
- Acronym / sponsor ID
- CLEAR / RUI-KN5501-SIL01
- Conditions
- Systemic Lupus Erthematosus (SLE)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Ruitherapeutics Co., LTDIndustry (pharma, biotech, devices)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Jan 2026 (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.
The goal of this clinical trial is to learn about the safety, pharmacokinetics and pharmacodynamics profile of KN5501 cell injection in adults with systemic lupus erythematosus(SLE). It will also learn if KN5501 cell injection works to treat refractory SLE. The main questions it aims to answer are:
- Is KN5501 cell injection safe in adults with SLE? And the maximum tolerated dose?
- Does KN5501 cell injection lower the disease activity of SLE in adults with refractory SLE？
Participants will:
Receive one or multiple (3 to 5 times) intravenous infusion of KN5501 cell injection at inpatient ward after lymphodepletion.
Visit the clinic at predefined frequency (from 1 week interval to 12-16 weeks' interval) for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Part 1(SAD)：establish Maximum Tolerated Dose for single-dose setting, and dosing regimen for MAD; Part 2(MAD and expansion): establish Recommended Phase 2 Dose(RP2D)
| Arm | Type | Receives |
|---|---|---|
| KN5501 cell injection | Experimental | Drug: KN5501 cell injectioninter-patient dose escalation arm with six dose levels for single-dose setting and 2-4 dose levels for multiple-dose setting |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Aged 18~70(including thresholds) when obtaining informed consent;
- 2. Body weight > 40.0 kg at screening;
- 3. Refractory SLE patients with moderate to severe activity;
- 4. CBC meeting predefined requirements at screening, including ANC ≥ 1.5×10^9/L, Hb ≥ 80g/L, and PLT ≥ 50×10^9/L(Not applicable, if it is ITP due to active SLE disease which is judged by investigator);
- 5. Adequate liver, kidney, lung and ;heart function at screening;
Key exclusion criteria (10 listed)
- 1. Hypersensitive or allergic to any components of KN5501(e.g. DEXTRAN 40) or other trial interventions including fludarabine, cyclophosphamide, and tocilizumab, or having ever experienced severe anaphylaxis;
- 2. Severe lupus nephritis patients, defined as proteinuria ≥3.5g/24h or a history of renal replacement therapy. Or high risk of progressive LN disease which will probably require induced intensive treatment;
- 3. CNS affected, including but not limited to lupus encephalopathy, seizure, strock(ischemic or hemorrhagic), dementia, cerebellar disease, organic brain syndrome, encephalitis, CNS vasculitis, or mental disease;
- 4. Severe lung disease, e.g. pulmonary hypertension ≥ grade 3(WHO), or requiring mask oxygen therapy or ventilator-assisted breathing(non-invasive or invasive) ;
- 5. Unstable cardiovascular system, e.g. myocardial infarction within 6 months before screening, unstable angina within 3 months before screening, uncontrolled and clinically significant ventricular arrhythmia(including ventricular tachycardia, ventricular fibrillation, or TdP), second-degree atrioventricular block of Mobitz type II or third-degree atrioventricular block, congestive heart failure with New York Heart Association class ≥ 3; poorly controlled hypertension (SBP > 160 mmHg and/or DBP > 100 mmHg), or accompanied by hypertensive crisis or hypertensive encephalopathy;
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 |
|---|---|---|
| KN5501 cell injectionIn Part 1(SAD), six different doses will be explored to establish maximum tolerated dose for single-dose setting; In part 2(MAD and expansion), about 2-4 multiple-dose dosing regimen will be explored, and cohorts of 1-2 dosing regimen will be selected to expand. | Drug | KN5501 cell injection |
Primary outcome
Dose Limiting Toxicity
Time frame: from the first dose to 2 weeks (SAD) or 4 weeks (MAD)
Number of participants with adverse events
Time frame: from enrollment to the last assessment at 52 weeks
Number of participants with adverse events(including abnormal physical examinations(PE), abnormal vital signs, abnormal laboratory test results and abnormal 12-ECG readings
11 secondary outcomes
Time to Peak Plasma Concentration (Tmax)
Time frame: from the first dose to 4 weeks.
Peak Plasma Concentration (Cmax)
Time frame: from the first dose to 4 weeks
Area under the plasma concentration versus time curve (AUC)
Time frame: from the first dose to 4 weeks.
Duration of retention
Time frame: from the first dose to 4 weeks
Number of CD19+ B cells per microlitre in peripheral blood (PD biomarker)
Time frame: from enrollment to the last assessment at 52 weeks
Concentration of cytokines (IL-6, etc.) in peripheral blood (PD biomarker)
Time frame: from enrollment to the last assessment at 52 weeks
Concentration of immunoglobulins (IgG, IgM, IgE and IgA) in peripheral blood (PD biomarker)
Time frame: from enrollment to the last assessment at 52 weeks
Concentration of serum complements (PD biomarker)
Time frame: from enrollment to the last assessment at 52 weeks
Number or percentage of B cell subsets in peripheral blood (PD biomarker)
Time frame: from enrollment to the last assessment at 52 weeks
Response rate of DORIS 2021(The 2021 Definitions Of Remission In SLE)
Time frame: from enrollment to the last assessment at 52 weeks
Response rate of LLDAS (Lupus Low Disease Activity Status)
Time frame: from enrollment to the last assessment at 52 weeks
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 22 Jan 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication will be shared.
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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.
Mengtao Li principal investigator
Rheumatology Department, Peking Union Medical College Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KN5501 cell injection in people with Systemic Lupus Erthematosus (SLE), run by Ruitherapeutics Co., LTD at 6 sites 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 8 inclusion and 10 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
Contact Medical Lead (+86 13810097396, yunpeng.zhang@ruitherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: from the first dose to 2 weeks (SAD) or 4 weeks (MAD)). The study lists 2 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 22 Jan 2026.