Anti-CD19/BCMA CAR-NK Cells in Patients With B Cell Mediated Autoimmune Disease

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT06792799
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Autoimmune Diseases
  • IgAN - IgA Nephropathy
  • Multi-Drug Resistant Nephrotic Syndrome
  • Systemic Lupus Erthematosus

Eligibility Criteria

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

Interventions

  • anti-CD19/BCMA CAR NK cells (KN5601) — BIOLOGICAL
    Patients will receive Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) on day -5, -4, and -3. Multiple doses of anti-CD19/BCMA CAR NK cells (KN5601) will infused in each group using dose-escalation strategy.

Study Details

this is an investigator-initiated trial aimed at evaluating the efficacy and safety of anti-CD19/BCMA CAR-NK Cells in Patients With B cell mediated autoimmune disease.

Key Dates

First listed
Jan 27, 2025
Start date
Jan 30, 2025
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: anti-CD19/BCMA CAR NK cells
    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.

Primary Outcome Measure

The safety of CAR-NK cell therapy in patients with B cell mediated autoimmune disease [ Time Frame: 1 months ]

Central Contacts

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