Study of Ultra-Fast CD19 CAR-T Therapy for Refractory SLE
NCT07331467 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2026-01-12
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
CD19 CAR-T cells
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.
Sponsors & Collaborators
-
Chongqing Precision Biotech Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-07-31
- Completion
- 2028-08-31
Countries
- China
Study Locations
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