drugset / Trial / NCT06983951

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

NCT06983951 ↗

Recruiting 30 enrolled Beijing Boren Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-02-20
Primary completion
2027-09-30
Completion
2027-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject BJBR-BCMA-006 Cell therapy — Intravenous

Indications