Exploratory Clinical Study of Second-generation CD19/BCMA Chimeric Antigen Receptor NK Cell Injection in Treating Paediatric B Cell-related Autoimmune Diseases

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07283315
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Autoimmune Diseases
  • CAR
  • Paediatric B Cell-related Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
3 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • anti-CD19/BCMA CAR NK cells (KN5601-K) — BIOLOGICAL
    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 Details

Evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Paediatric B cell-related autoimmune diseases

Key Dates

First listed
Dec 15, 2025
Start date
Dec 3, 2025
Status verified
Jan 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: anti-CD19/BCMA CAR NK cells

Primary Outcome Measure

Incidence and severity of dose-limiting toxicity (DLT) and treatment-emergent adverse events (TEAEs) [ Time Frame: 1 month ]

Central Contacts

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