RecruitingNot Applicable

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

China30 participantsStarted 2025-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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;
✕. dFLC \> 50mg/L
✕. Expected survival period ≥ 12 weeks;
✕. ECOG score ≤ 2 points;
✕. Female subjects with fertility should agree to take effective contraceptive measures from the date of signing the informed consent form until 365 days after reinfusion. Effective contraceptive measures are defined as abstinence or using contraceptive methods with an annual failure rate of less than 1% as specified in the plan;

What they're measuring

Frequency Of AES, SAES

Timeframe: 0 day to 24 months after treatment

Dose Limiting Toxicity

Timeframe: 0~28 day after treatment

Trial details

NCT IDNCT06983951

SponsorBeijing Boren Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-30

Contact for this trial

yajing zhang, MD/PhD

+8601083605002(716) zhangyj3@gobroadhealthcare.com

View on ClinicalTrials.gov More Light Chain Amyloidosis trials