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

ConditionsRheumatic DiseasesPediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)Systemic Lupus Erythematosus (SLE)Connective Tissue Disease-associated Interstitial Lung Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorThe Children's Hospital of Zhejiang University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

. Gender unrestricted, age ≥5 years;

. The patient or their legal guardian agrees to participate in this clinical trial and signs the informed consent form, indicating their understanding of the trial's purpose and procedures and willingness to participate;

. Peripheral blood B cells confirmed by flow cytometry to express CD19, with a B cell count >5 cells/uL;

. If previously treated with B cell-targeted therapy, peripheral blood B cell count at screening has returned to normal or above the pre-treatment level;

Disqualifiers

. 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).

Trial design

Design model

Single group

Treatments tested in this trial

  • KN5601

    Biological/Vaccine

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

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: Experimental: KN5601Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
up to 28 days after infusion

Secondary outcomes

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

Time frame
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.

Time frame
up to 52 weeks after infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Children's Hospital of Zhejiang University School of Medicine

Lead sponsor

Rui Therapeutics Co., Ltd

Collaborator

Source ClinicalTrials.gov
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