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Systemic Lupus Erythematosus (SLE)Early Phase 1NCT06010472

An Exploratory Clinical Study of Anti-CD19 CAR NK Cells in the Treatment of Systemic Lupus Erythematosus

A Early Phase 1 study testing anti-CD19 CAR NK cells (KN5501) in people with Systemic Lupus Erythematosus (SLE), run by Changhai Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-cluster of differentiation antigen 19 (CD19) chimeric antigen receptor (CAR) natural killer (NK) cells (KN5501) in patients with moderate to severe refractory systemic lupus erythematosus (SLE). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
anti-CD19 CAR NK cells (KN5501)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
20 Aug 2023to 25 Aug 2027
Phase
Early 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥ 18 years old and ≤ 65 years old, male or female, subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF)
  • Previous diagnosis of systemic lupus erythematosus (SLE) (according to the 1997 American Rheumatology Association criteria)
  • Females of childbearing potential must use effective contraception during study treatment and for 90 days after the last dose of study treatment. In addition, subjects must not donate eggs during the study and for at least 90 days after the last dose of study treatment
  • Subjects with Systemic Lupus Erythematosus Disease Activity Index (SLEDAI-2K) score ≥ 8 points prior to screening
  • Subject has ≥ 1 organ system with BILAG-2004 Class A mobility score or ≥ 2 organ systems with BILAG-2004 Class B mobility score prior to screening
  • Subjects meets one of the following:
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  • Antinuclear antibody (ANA) ≥ 1:80, determined by immunofluorescence method;
  • Anti-dsDNA antibodies are higher than normal level;
  • Anti-Smith antibodies are higher than normal level
  • Absolute number of neutrophils ≥ 1.0×10^9/L, hemoglobin ≥ 60g/L
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • Subjects have been treated with oral corticosteroids (OCS) in combination with an immunosuppressive or biologic agent for at least 6 months prior to enrollment

Who cannot join

  • Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, obinutuzumab), or subjects with a history of severe allergic reactions
  • Subjects with active infection receiving intravenous (IV) antibiotic treatment, or received intravenous (IV) antibiotic treatment within one week prior to anti-CD19 CAR NK Cells infusion
  • Subjects with acquired and congenital immunodeficiency diseases
  • Subjects with grade III or IV heart failure (NYHA classification)
  • History of epilepsy or other central nervous system (CNS) diseases
  • History of severe herpetic infection, such as herpetic encephalitis, ocular herpes, or diffuse herpes
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  • History of other primary malignant tumors except:
  • Cured non-melanoma skin cancer by surgical excision, for example basal cell carcinoma (BCC) ;
  • Cured primary malignant tumors, such as cervical cancer, superficial bladder cancer, breast cancer
  • Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening; History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of anti-CD19 CAR NK Cells (KN5501), except for lupus (determined by the investigator)
  • Females who are pregnant, lactating, or planning a pregnancy within six months
  • 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
  • Subjects who have received other clinical trial treatment within 3 months
  • Subjects who have received B cell-targeted drug therapy within 1 month before enrollment
  • Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria
  • Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongbao Zhao, Doctor contact

+86-15921061314

dongbaozhao@163.com

China1 site, 1 recruiting

  • Changhai Hospital

    Shanghai

    Dongbao Dongbao Zhao, Doctor, +86-15921061314, dongbaozhao@163.com

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of the Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor (CAR) Nature Killer Cells (KN5501) in the Treatment of Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE)

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-cluster of differentiation antigen 19 (CD19) chimeric antigen receptor (CAR) natural killer (NK) cells (KN5501) in patients with moderate to severe refractory systemic lupus erythematosus (SLE). 36 patients are planned to be enrolled in the dose-escalation trial. The primary objective of the study was to evaluate the safety of allogeneic anti-CD19 CAR-NK cells (KN5501) for the treatment of patients with moderate to severe refractory active SLE. The secondary objective is to evaluate the efficacy of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE, including British Isles Lupus Assessment Group 2004 (BILAG-2004) index, Systemic Lupus Erythematosus Responder Index (SRI)-4 response rate, Lupus Low Disease Activity State (LLDAS) rate, and Definitions Of Remission In SLE (DORIS) remission rate.

Being tested
anti-CD19 CAR NK cells (KN5501)
Keywords
Lupus Erythematosus, Systemic, Autoimmune disorders, Connective Tissue Diseases
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • anti-CD19 CAR NK cells (KN5501)Drug

    Patients will receive Fludarabine (25 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Multiple doses of anti-CD19 CAR NK cells (KN5501) will infused in each group using the "3 + 3" dose-escalation strategy.

Study groups in NCT06010472
Study groupRoleWhat they receive
anti-CD19 CAR NK cellsExperimentalTo evaluate the safety and effectiveness of anti-CD19 CAR NK cells (KN5501) in patients with moderate to severe refractory SLE. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19 CAR NK cells infusion.
Receives: Drug: anti-CD19 CAR NK cells (KN5501)

What is being measured

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

  1. Incidence of Dose Limiting Toxicity (DLTs)

    To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe refractory SLE

    Measured: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion

  2. Incidence of Treatment Emergent Adverse Events (TEAEs)

    To characterize the safety of anti-CD19 CAR NK Cells for moderate to severe refractory SLE

    Measured: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion

Secondary outcomes (3)

  1. SRI-4 response rate of subjects

    To characterize the efficacy of anti-CD19 CAR NK Cells for moderate to severe refractory SLE

    Measured: 12, 24,36, and 52 weeks after infusion

  2. LLDAS rate of subjects

    To characterize the efficacy of anti-CD19 CAR NK Cells for moderate to severe refractory SLE

    Measured: 12, 24,36, and 52 weeks after infusion

  3. DORIS remission rate of subjects

    To characterize the efficacy of anti-CD19 CAR NK Cells for moderate to severe refractory SLE

    Measured: 12, 24,36, and 52 weeks after infusion

Timeline

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

  1. First posted24 Aug 2023
  2. Study start20 Aug 2023
  3. Primary completion25 Aug 2026 (estimated)
  4. Study completion25 Aug 2027 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06010472
Sponsor's protocol ID
CHEC2023-174
Status last verified
Jul 2024
First submitted
7 Aug 2023
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gao J, Li M, Sun M, Yu Y, Kong R, Xu X, Liu S, Chen Q, Li X, Wu Y, Xu E, Yang J, Zhao D. Efficacy and safety of allogeneic CD19 CAR NK-cell therapy in systemic lupus erythematosus: a case series in China. Lancet. 2026 Dec 20;406(10522):2968-2979. doi: 10.1016/S0140-6736(25)01671-X. Epub 2025 Nov 12.

    PubMed 41240964

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing anti-CD19 CAR NK cells (KN5501) in people with Systemic Lupus Erythematosus (SLE), run by Changhai Hospital 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 12 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Dongbao Zhao, Doctor (+86-15921061314, dongbaozhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicity (DLTs) (time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion). 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?

On the ClinicalTrials.gov record for NCT06010472, 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 29 Apr 2025.

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