Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE

Sponsor
The Children's Hospital of Zhejiang University School of Medicine
Study ID
NCT07233642
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • CD19 CAR-T cells — BIOLOGICAL
    Three dose groups (1.5×10\^5/kg, 5×10\^5/kg, 10×10\^5/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Study Details

This is an investigator-initiated trial aimed at assessing the safety and efficacy of ultra-fast autologous CD19-targeted CAR-T cells in the treatment of refractory systemic lupus erythematosus.

Key Dates

First listed
Nov 18, 2025
Start date
Nov 30, 2025
Status verified
Nov 2025
Primary completion
May 31, 2026
Completion
Sep 30, 2028

Study Design

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

Arms

  • Experimental: CAR-T treatment group
    This trial was designed as an open, single-arm, single-center, dose-increasing trial.

Primary Outcome Measure

The safety of CAR-T cell therapy in patients with refractory SLE [Safety] [ Time Frame: 3 months ]

Central Contacts

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