About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Participants must personally sign the informed consent form approved by the ethics committee in writing before the start of the study;
The age of the subject is ≥ 18 years old;
Diagnosed with light chain amyloidosis through pathological examination;
Subjects with recurrent/refractory light chain amyloidosis who have previously received second-line or higher treatment;
Trial design
Single group
Treatments tested in this trial
BCMA CART
GeneticThe 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
Treatment groups
Trial outcomes
Primary outcomes
Frequency Of AES, SAES
Dose Limiting Toxicity
Sponsors and contacts
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