Safety and Efficacy of KSVCBD Injection in Autoimmune Diseases
NCT07613411 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2026-05-29
Summary
KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This single-arm, open-label, early exploratory clinical study is designed to evaluate the safety and preliminary efficacy of KSVCBD injection in patients with Autoimmune Diseases.
Conditions
Interventions
- DRUG
-
KSVCBD injection
KSVCBD injection is an in vivo CAR-T therapy targeting CD19/BCMA and is administered by IV infusion.
Sponsors & Collaborators
-
Chinese PLA General Hospital
lead OTHER
Principal Investigators
-
Jian Zhu · Rheumatology Department of Chinese PLA General Hospital
-
Weidong Han · Biotherapeutic Department of Chinese PLA General Hospital
-
Yang Liu · Biotherapeutic Department of Chinese PLA General Hospital
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
- 2026-06-01
- Primary Completion
- 2028-12-31
- Completion
- 2029-03-31
Countries
- China
Study Locations
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