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NOT YET RECRUITING
NCT07592754
EARLY_PHASE1

The Safety and Efficacy of KSVCBD Injection in Neuromyelitis Optica Spectrum Disorder.

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

KSVCBD injection is an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy product. This is a multi-center, single-arm, open-label, early exploratory clinical study. The objective of this study is to evaluate the safety and preliminary efficacy of KSVCBD injection in AQP4-positive Neuromyelitis Optica Spectrum Disorder

Official title: An Early Exploratory Clinical Study on the Safety and Efficacy of KSVCBD Injection in the Treatment of Relapsed/Refractory AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-05-15

Completion Date

2029-03-31

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

KSVCBD injection

KSVCBD injection is a CD19/BCMA-targeted in vivo-edited CAR-T cell injection. Three dose levels are predefined, and KSVCBD will be dose-escalated per the protocol-specified doses.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China