NCT06633042

The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory NMOSD

The Safety and Efficacy of Universal CAR-T Cells Targeting BCMA in the Treatment of Refractory AQP4 Antibody Positive Neuromyelitis Optica Spectrum Disease

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Bioray Laboratories · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, Multi-center，dose-escalation study in up to 18 participants with refractory NMOSD. This study aims to evaluate the safety and efficacy of universal CAR-T Cells targeting BCMA in the Treatment of refractory NMOSD.

Detailed description

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects. Based on the "3 + 3" dose escalation design principle, subjects will be divided into 3 groups from low dose to high dose in sequence (Group A; Group B; Group C).

Conditions

• Autoimmune Disease

Interventions

Type	Name	Description
DRUG	Universal BCMA-CD19 CART	1.0-4.0×10\^6 CAR-T cells/kg

Timeline

• Start date: 2024-11-25
• Primary completion: 2025-10-12
• Completion: 2025-12-12
• First posted: 2024-10-09
• Last updated: 2024-11-12