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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Boren Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • BCMA CART

    Genetic

    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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: BCMA CARTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Frequency Of AES, SAES

Time frame
0 day to 24 months after treatment
2

Dose Limiting Toxicity

Time frame
0~28 day after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

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