NCT06983951

Exploratory Clinical Study on the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent/Refractory Light Chain Amyloidosis

Exploratory Clinical Study Evaluating the Safety and Efficacy of Targeted BCMA Autologous CART Cell Injection in Subjects With Recurrent/Refractory Light Chain Amyloidosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Beijing Boren Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, open label, fixed dose exploratory clinical trial with an expected enrollment of 30 subjects. The main objective is to evaluate the safety of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, preliminarily verify the effectiveness of targeted BCMA autologous CART cell injection in the treatment of recurrent or refractory light chain amyloidosis in subjects, and explore the pharmacokinetic, pharmacodynamic, and immunogenic characteristics of targeted BCMA autologous CART cell injection after reinfusion.

Conditions

• Light Chain Amyloidosis

Interventions

Type	Name	Description
GENETIC	BCMA CART	The cell product used in this study is a targeted BCMA autologous CART cell injection. Research drug name: Targeted BCMA Autologous CART Cell Injection Drug code: BJBR-BCMA-006 Administration method: single intravenous injection

Timeline

• Start date: 2025-02-20
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: China