Recruiting

SEEKAnti-CD19/BCMA CAR-NK Cells for B Cell Mediated Autoimmune Disease

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What is being tested

anti-CD19/BCMA CAR NK cells (KN5601)

Biological
Who is being recruted

Urogenital Diseases+10

+ Autoimmune Diseases

+ Female Urogenital Diseases and Pregnancy Complications

Over 3 Years
+39 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Early Phase 1
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorThe Children's Hospital of Zhejiang University School of Medicine
Study ContactJianhua Mao, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 30, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new treatment using CAR-NK cells for people with certain autoimmune diseases, specifically systemic lupus erythematosus (SLE) and multi-drug resistant nephrotic syndrome (MDR-SRNS). These conditions occur when the immune system mistakenly attacks healthy tissues, leading to serious health problems, including organ damage. Current treatments are not effective for everyone, especially children with SLE who often experience more severe symptoms. There's a significant need for new treatments, as many patients struggle to achieve remission. CAR-NK cell therapy, a method that uses modified immune cells to target disease-related cells, may offer a safer, more affordable, and effective alternative to existing therapies. Participants in this study will receive CAR-NK cells, which are specially engineered immune cells designed to target and destroy harmful cells in the body, through an injection. The study aims to assess the safety and effectiveness of this treatment approach. Researchers will closely monitor participants for any changes in their condition and check for potential side effects. This early phase study hopes to provide insight into whether CAR-NK cell therapy can be a viable treatment option for these challenging autoimmune diseases, potentially improving outcomes for patients who have not responded well to other treatments.

Official TitleAn Exploratory Clinical Study on the Safety and Efficacy of CD19/BCMA Chimeric Antigen Receptor NK Cells in the Treatment of B Cell-related Autoimmune Diseases in Children
NCT06792799
Principal SponsorThe Children's Hospital of Zhejiang University School of Medicine
Study ContactJianhua Mao, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

36 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 3 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAutoimmune DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGlomerulonephritisGlomerulonephritis, IGAImmune System DiseasesKidney DiseasesNephritisNephrosisNephrotic SyndromeUrologic DiseasesFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

21 inclusion criteria required to participate
Age:≥5 years old;

ECOG: 0\~2;

Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-NK infusion;

No history of macrophage activation syndrome (MAS) within one month prior to screening.

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18 exclusion criteria prevent from participating
Patients with malignant diseases such as tumors before screening, or with other serious life-threatening diseases;

Secondary or congenital immunodeficiency.

Received live vaccine within 4 weeks before screening;

Subjects who have received B cell-targeted drug therapy within 1 month before enrollment

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
The study adopted a dose-escalation and expansion study design. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA CAR NK cells infusion.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000

Hangzhou, ChinaOpen Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000 in Google Maps
Recruiting
One Study Center