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Rheumatic DiseasesEarly Phase 1Cell therapyNCT07490041

Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases

A Early Phase 1 study testing KN5601 in people with Rheumatic Diseases and Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), run by The Children's Hospital of Zhejiang University School of Medicine 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-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases. Read more about this study

Who is it for?
Ages 5 years and older
What is being tested?
KN5601
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
19 Mar 2026to 19 Dec 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 5 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • . History of malignancy (except for basal cell or squamous cell skin cancer or carcinoma in situof the cervix that has been excised and cured for at least 5 years), or current malignancy.
  • . Known allergy, hypersensitivity, intolerance, or contraindication to CD19/BCMA CAR-NK cells or any component of the drugs that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or subjects who have experienced a severe allergic reaction in the past.
  • . Evidence of severe active viral or bacterial infection, or uncontrolled systemic fungal infection at screening or baseline visits, or subjects with active or uncontrolled infection requiring parenteral antimicrobial therapy.
  • . Subjects with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) functional classification (see Appendix).
  • . Subjects with congenital heart disease, or history of acute myocardial infarction within 6 months prior to screening, or severe arrhythmia (including multifrequent ventricular premature beats, supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs requiring vasopressors to maintain blood pressure.
  • . Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels above the normal reference range in peripheral blood at screening; OR positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels above the normal reference range; OR positive human immunodeficiency virus (HIV) antibody; OR positive syphilis test; OR positive cytomegalovirus (CMV) DNA test.
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  • . History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella, herpes zoster) within 12 weeks prior to screening.
  • . Current active tuberculosis or history of active tuberculosis, or subjects whose interferon-gamma release assay for tuberculosis infection cannot yield a negative result during the screening period.
  • . Subjects with interstitial lung disease (ILD), meeting any of the following conditions are excluded: Forced vital capacity (FVC) <50% of predicted value at screening, OR diffusing capacity of the lungs for carbon monoxide (DLCO) <40% of predicted value; Requiring long-term oxygen therapy or non-invasive ventilation; Acute exacerbation of interstitial pneumonia/acute respiratory failure within the past 6 months, or hospitalization due to ILD requiring intravenous pulse corticosteroid therapy; Rapidly progressive ILD as judged by the investigator.
  • . Subjects with pulmonary arterial hypertension (PAH), meeting any of the following conditions are excluded: Results from right heart catheterization or echocardiography (non-invasive estimation) meeting any of the following: a. Estimated systolic pulmonary artery pressure (sPAP) >50 mmHg (assessed in conjunction with tricuspid regurgitation velocity); b. Diagnosis of WHO functional class III or IV PAH.
  • Hospitalization within the past 6 months due to acute exacerbation of PAH or right heart failure; Requiring intravenous prostacyclin analog therapy during the screening period; Presence of signs of right ventricular dysfunction, including but not limited to ascites, hepatic congestion, peripheral edema, accompanied by significantly elevated BNP/NT-proBNP levels and clinically unstable symptoms.
  • . History of epilepsy or other active central nervous system diseases.
  • . Subjects with acquired or congenital immunodeficiency diseases.
  • . History of any clinically significant cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal disease, or other major condition that, in the investigator's judgment, precludes the administration of KN5601.
  • . Solid organ or hematopoietic stem cell transplantation within 3 months prior to screening; OR acute graft-versus-host disease (GVHD) of grade 2 or higher within 2 weeks prior to screening.
  • . Vaccination with a live vaccine within 4 weeks prior to screening.
  • . Having received the following treatments within the specified time frames prior to the baseline visit: B cell depletion therapy within 26 weeks; Within 24 weeks prior to randomization: Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor alpha (anti-TNFα) biologics, immunoglobulin, plasmapheresis; Within 12 weeks prior to randomization: JAK inhibitors or other kinase inhibitors, unless explicitly permitted by the protocol; Use of traditional Chinese medicines, proprietary Chinese medicines, or health products containing Tripterygium wilfordii(Lei Gong Teng), Tripterygium hypoglaucum(Kunming Shan Hai Tang), Colquhounia coccineavar. mollis(Huo Ba Hua Gen), or white peony root (Paeonia lactiflora, Bai Shao) within 4 weeks; Within 3 half-lives of prior therapy, OR within 4 weeks, OR until the expected pharmacodynamic effects have returned to baseline levels (whichever is longer); B cell count below the lower limit of normal or baseline value (whichever is lower) following prior B cell depletion therapy.
  • . Participation in any clinical trial within three months.
  • . Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the trial results.

Trial locations and contacts

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

Meiping Lu, Prof. contact

+86-13685773988

12218532@zju.edu.cn

China1 site, 1 recruiting

  • The Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Yiyi Xie, Prof., 86670072, chkjk@zju.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA CAR-NK Cell Injection for the Treatment of Relapsed/Refractory Pediatric Rheumatic Diseases

A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.

Being tested
KN5601
Medical subject headings
Rheumatic Diseases, Arthritis, Lupus Erythematosus, Systemic

What participants receive

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

  • KN5601Biological

    Multiple doses of anti-CD19/BCMA CAR-NK cells (KN5601) will be administered using dose-escalation strategy.

Study groups in NCT07490041
Study groupRoleWhat they receive
Experimental: KN5601ExperimentalPatients will receive Fludarabine and Cyclophosphamide on day-5, -4, and -3. Multiple doses of anti-CD19/BCMA CAR-NK cells (KN5601) will be administered using dose-escalation strategy.
Receives: Biological: KN5601

What is being measured

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

  1. Incidence of Dose-Limiting Toxicity (DLT)

    To characterize the safety of anti-CD19/BCMA CAR NK Cells (KN3601) for patients with Refractory Pediatric Rheumatic Diseases.

    Measured: up to 28 days after infusion

Secondary outcomes (2)

  1. The proportion of subjects who achieved clinical remission, or clinical inactive status at months 3, 6, 9, and 12.

    To characterize the efficacy of anti-CD19/BCMA CAR NK Cells (KN5601) for patients with Relapsed/Refractory autoimmune diseases

    Measured: up to 52 weeks after infusion

  2. B cell depletion rate

    To characterize the efficacy of anti-CD19/BCMA CAR NK Cells (KN5601) for patients with Refractory Pediatric Rheumatic Diseases.

    Measured: up to 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 Mar 2026
  2. Study start19 Mar 2026 (estimated)
  3. Primary completion19 Dec 2026 (estimated)
  4. Study completion19 Dec 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
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07490041
Sponsor's protocol ID
2025-SC-0006-P-02
Acronym
Cell therapy
Status last verified
Mar 2026
First submitted
18 Mar 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing KN5601 in people with Rheumatic Diseases and Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), run by The Children's Hospital of 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 0 inclusion and 19 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 24 Mar 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.

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 Meiping Lu, Prof. (+86-13685773988, 12218532@zju.edu.cn), 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 (DLT) (time frame: up to 28 days after infusion). 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 NCT07490041.

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 24 Mar 2026.

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