Safety and Efficacy Study of CD19-CAR-DNT Cells in Autoimmune Diseases
NCT06316076 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2024-03-18
Summary
To evaluate the safety and efficacy of CD19-CAR-DNT cells in subjects with relapsed/refractory autoimmune diseases
Conditions
- Systemic Lupus Erythematosus
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Idiopathic Inflammatory Myopathies
- Systemic Sclerosis
Interventions
- BIOLOGICAL
-
CD19-CAR-DNT cells
Lentiviral vector-transduced DNT cells to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.
Sponsors & Collaborators
-
Guangdong Ruishun Biotech Co., Ltd
collaborator INDUSTRY -
RenJi Hospital
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-30
- Primary Completion
- 2024-06-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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