Cluster of Differentiation 19 (CD19)/B Cell Maturation Antigen (BCMA) Chimeric Antigen Receptor T-Cell (CAR-T) Therapy for Refractory Autoimmune Diseases
- Sponsor
- Shenzhen Genocury Biotech Co., Ltd.
- Study ID
- NCT07490951
- Status
- Not Yet Recruiting
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Conditions
- Autoimmune Diseases
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- CD19/BCMA-targeted CAR-T lentiviral vector drug — DRUGThe CD19/BCMA-targeted CAR-T lentiviral vector drug is administered intravenously, and autologous CD19/BCMA-targeted CAR-T cells are produced in the patient's body following infusion.
Study Details
This study is an investigator-initiated single center, single arm clinical study with a target population of patients with refractory autoimmune diseases. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of CD19/BCMA CAR-T in the treatment of refractory autoimmune diseases.
Key Dates
- First listed
- Mar 24, 2026
- Start date
- Mar 22, 2026
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 20 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CD19/BCMA CAR-T for the treatment of refractory autoimmune diseasesSubjects who meet the inclusion criteria will receive intravenous infusion of the CD19/BCMA-targeted CAR-T lentiviral vector drug. Following infusion, CD19/BCMA-targeted CAR-T cells will be generated in vivo.
Primary Outcome Measure
Incidence of adverse events(AE) after infusion [ Time Frame: Day 28, Month 2, Month 3, Month 6, Month 12, Month 18, Month 24 ]
Central Contacts
- Liang Zou, Doctor+86 186 0270 1800
- Xiaoya Du+86 27 8533 2028
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