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Systemic Lupus ErythematosusPhase 1NCT06421701

Anti-CD19 CAR-NK Cells in Refractory/Relapsed Systemic Lupus Erythematosus

A Phase 1 study testing anti-CD19 CAR-NK cells in people with Systemic Lupus Erythematosus, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a single-center, open-label, single-arm trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
anti-CD19 CAR-NK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
1 Aug 2024to 31 May 2026
Phase
Phase 1
Are there results?
None posted in the registry

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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up;
  • Age range from 18 to 65 years old, regardless of gender;
  • Fulfilling the 2019 ACR/EULAR classification criteria of SLE;
  • Presence of anti-dsDNA or decreased C3/C4 levels;
  • SLEDAI-2K≥8；
  • Routine treatment is ineffective or the disease relapses after remission. Definition of routine treatment: use more than two drugs, including glucocorticoid (more than 1mg/kg/d), and any two or more of the following immunomodulatory drugs for more than 6 months: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, leflunomide, tacrolimus, ciclosporin, iguratimod, biological agents, including rituximab, belizumab, or telitacicept；
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  • Hemoglobin ≥ 80g/L; white blood cell count ≥ 3 × 10^9/L；neutrophil count ≥ 1.5 × 10^9/L; platelets ≥ 30 × 10^9/L;
  • The functions of important organs are basically normal: ALT ≤ 2 × ULN; AST ≤ 2 × ULN; eGFR ≥ 30ml/min/1.73m2; total bilirubin ≤2.0 mg/dL; cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%; non-oxygenated blood oxygen saturation >94%; prothrombin time (PT) ≤ 1.5 × ULN；international standardized ratio (INR) ≤ 1.5 × ULN；
  • Females of childbearing potential must use effective contraception during the study.

Who cannot join

  • History of severe allergy or known hypersensitivity to any of the active ingredients of the cell product；
  • Pregnant (or lactating) women;
  • Severe lupus nephritis (defined as serum creatinine > 2.5 mg/dL or 221 μmol/L), treatment with hemodialysis within 8 weeks prior to screening；
  • Other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis within 8 weeks prior to screening；
  • Combined with other autoimmune diseases requiring systemic therapy except for secondary sjogren's syndrome;
  • Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis;
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  • Abnormal test results for hepatitis B or C indicate the presence of an active or chronic infection, including positive HBsAg or positive HBcAb with HBV DNA levels exceeding the normal upper limit，positive hepatitis C antibody and detectable HCV RNA；positive serology for human immunodeficiency virus (HIV) or a known history of HIV infection; patients who test positive for HBsAg, have HBV DNA levels within the normal range, and are willing to reveive full-course antiviral therapy for hepatitis B are allowed to participate in this trial.
  • Cytomegalovirus DNA levels in the peripheral blood exceeding the normal upper limits；
  • Active or latent tuberculosis；
  • Presence of uncontrollable bacterial, fungal, viral or other infections, requiring antibiotic therapy;
  • Acquired and congenital immunodeficiency diseases；
  • IgA deficiency;
  • Other uncontrolled diseases: acute or chronic diseases that are clinically unstable or have not been effectively controlled and are not related to SLE；
  • History of malignant diseases such as malignant tumors, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, superficial bladder cancer, breast cancer;
  • Any active skin disease that may interfere with the study assessment of SLE, including but not limited to psoriasis, dermatomyositis, systemic sclerosis, non-LE cutaneous lupus manifestations (eg, cutaneous vascular disease, periungual telangiectasia, fingertip sclerosis, rheumatoid nodules, erythema multiforme, leg ulcers) or drug-induced lupus；
  • Prior treatment with cell therapy or any prior gene therapy product；
  • Contraindication to cyclophosphamide in combination with fludarabine;
  • Prior CD19-targeted therapy;
  • Received live vaccine treatment within 4 weeks prior to screening;
  • Subjects who have undergone major surgery within 8 weeks prior to screening, or who are scheduled to have surgery during the trial；
  • Have received B-cell targeted therapy within 4 weeks prior to screening;
  • Have received plasmapheresis within 3 months prior to screening;
  • Have participated in other clinical studies within 3 months prior to screening;
  • History of vital organ transplantation (eg, heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation；
  • Situations in which investigators consider it inappropriate to participate in the study.

Trial locations and contacts

1 site in 1 country.

Huaxiang Wu, PhD contact

86-13757118395

wuhx8855@zju.edu.cn

China1 site, 1 recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, China, 310016

    Huaxiang Wu, PhD, 86-13757118395

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of Anti-CD19 CAR-NK Cells in the Treatment of Refractory/Relapsed Systemic Lupus Erythematosus

This study is a single-center, open-label, single-arm trial. The aim of this study is to investigate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus.

Being tested
anti-CD19 CAR-NK cells
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.

  • anti-CD19 CAR-NK cellsDrug

    Patients will receive Fludarabine and Cyclophosphamide for lymphodepletion conditioning. Anti-CD19 CAR-NK cells will be infused on Day 0, 3, and 6.

Study groups in NCT06421701
Study groupRoleWhat they receive
anti-CD19 CAR-NK cellsExperimentalTo evaluate the safety and efficacy of anti-CD19 CAR-NK cells in patients with refractory/relapsed systemic lupus erythematosus. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR-NK cells infusion on Day 0, 3, and 6.
Receives: Drug: anti-CD19 CAR-NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The proportion of subjects with adverse events

    Incidence and severity of AEs and SAEs, including changes in laboratory values and vital signs as assessed by CTCAE v5.0.

    Measured: 12 months

Secondary outcomes (10)

  1. Proportion of subjects with Systemic Lupus Erythematosus Responder Index-4 (SRI-4) response

    Proportion of patients with SRI-4 response: including SLEDAI-2000 ≥4-Point improvement, BILAG 2004 with no new A domain score AND no more than 1 new B domain scores, PGA with No worsening (<0.3-point increase).

    Measured: day 28, month 2, month 3, month 4, month 5, month 6, month 9 and month 12 after infusion.

  2. Proportion of participants achieving definition of remission in SLE (DORIS) remission

    The Definition of Remission in SLE (DORIS) is a standardized criterion to clearly define what constitutes remission in patients with systemic lupus erythematosus.

    Measured: day 28, month 2, month 3, month 4, month 5, month 6, month 9 and month 12 after infusion.

  3. Proportion of participants achieving Lupus Low Disease Activity State (LLDAS)

    The Lupus Low Disease Activity State (LLDAS) is a clinical treatment target designed for patients with systemic lupus erythematosus. It represents a state where the disease activity is kept at a low level, aiming to minimize symptoms and prevent long-term damage caused by the disease.

    Measured: day 28, month 2, month 3, month 4, month 5, month 6, month 9 and month 12 after infusion.

  4. Changes in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score from baseline

    Assessment of SLEDAI-2000 from baseline administration at various timepoints up to month 12 follow up visit.

    Measured: Within 12 months after anti-CD19 CAR-NK cell infusion

  5. Changes in the Physician Global Assessment (PGA) from baseline

    Assessment of PGA from baseline administration at various timepoints up to month 12 follow up visit.

    Measured: Within 12 months after anti-CD19 CAR-NK cell infusion

  6. Change in proteinuria measured by 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline

    Assessment of 24h proteinuria or urine protein creatinine ratio (UPCR) from baseline administration at various timepoints up to month 12 follow up visit.

    Measured: Within 12 months after anti-CD19 CAR-NK cell infusion

  7. Changes in level of anti-nuclear antibody (ANA) in peripheral blood from baseline

    Assessment of ANA from baseline administration at various timepoints up to month 12 follow up visit.

    Measured: Within 12 months after anti-CD19 CAR-NK cell infusion

  8. Changes in levels of complement C3 and C4 in peripheral blood from baseline

    Assessment of C3 and C4 from baseline administration at various timepoints up to month 12 follow up visit.

    Measured: Within 12 months after anti-CD19 CAR-NK cell infusion

  9. CMAX of anti-CD19 CAR-NK cells

    CMAX is defined as the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood.

    Measured: 12 months

  10. TMAX of anti-CD19 CAR-NK cells

    TMAX is defined as the time to reach the highest concentration of anti-CD19 CAR-NK cell expansion in the peripheral blood.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2024
  2. Study start1 Aug 2024
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06421701
Sponsor's protocol ID
2024-0530
Status last verified
May 2024
First submitted
13 May 2024
Last updated
25 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zeng Z, Lei W, Deng W, Chen M, Xu W, Zhu L, Xue J, Yuan M, Wang JQ, Ye Q, Zhang S, Wang Q, Qian W, Wu H. Safety and efficacy of low-dose, cord blood-derived CD19 CAR-NK cells with 4-1BB co-stimulation in refractory systemic lupus erythematosus. Med. 2026 Aug 14;7(8):101226. doi: 10.1016/j.medj.2026.101226. Epub 2026 Jul 22.

    PubMed 42486100

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-CD19 CAR-NK cells in people with Systemic Lupus Erythematosus, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 25 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: status not confirmed, as of the sponsor's last update on 25 May 2025. 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.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Huaxiang Wu, PhD (86-13757118395, wuhx8855@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects with adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06421701, which also lists 1 linked publication.

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 25 May 2025.

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