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

StatusWithdrawn
PhaseNot applicable
Started

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Record History

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  1. Stopped Trial status changed: Recruiting → Withdrawn Sponsor's reason: Due to the promulgation of State Council Order No. 818, clinical trials of this category are prohibited.
    • Enrollment target: estimated 30 to confirmed 0
    • Eligibility criteria expanded, about 25 words
    • Site details revised
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
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.
Trial Details
NCT Number NCT06983951
Lead Sponsor Beijing Boren Hospital
Conditions
(from sponsor)
Light Chain Amyloidosis
Related terms Immunoglobulin Light-chain Amyloidosis
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov