Efficacy and Safety of CD19 UCAR T Cells in Refractory Systemic Lupus Erythematosus
NCT06691152 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2024-11-15
Summary
This is an investigator-initiated trial to evaluate the safety and efficacy of CD19 Universal CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Conditions
Interventions
- BIOLOGICAL
-
CD19 Universal CAR-T cells
Three dose groups (1×10\^7/kg, 3×10\^7/kg, 6×10\^7/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
Sponsors & Collaborators
-
The Children's Hospital of Zhejiang University School of Medicine
lead OTHER
Principal Investigators
-
Jianhua Mao · Children's Hospital, Zhejiang University School of Medicine
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 5 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-10-30
- Primary Completion
- 2027-09-30
- Completion
- 2027-09-30
Countries
- China
Study Locations
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