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Autologous BCMA-targeted CAR-T Cell Injection for Relapsed/Refractory Light Chain Amyloidosis

NCT07626476 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-04

No results posted yet for this study

Summary

Systemic light chain amyloidosis (AL amyloidosis) is the most common type of systemic amyloidosis, with diverse clinical manifestations and difficulties in diagnosis and treatment. AL amyloidosis may involve multiple organs; the kidney and heart are the most commonly involved organs. The treatment goal is to reduce monoclonal immunoglobulin light-chain levels, prevent further amyloid deposition in important organs, and alleviate or reverse organ dysfunction caused by amyloid deposition. The principal approach to achieve this goal is to eliminate the plasma-cell or B-cell clones producing abnormal light chains. For patients with relapsed/refractory AL amyloidosis, the protocol states that there is currently no suitable treatment method and that participation in clinical trials is recommended.

This study evaluates targeted BCMA autologous CART cell injection in participants with relapsed/refractory light chain amyloidosis. The main purpose is to evaluate safety, preliminarily verify efficacy, and explore in vivo pharmacokinetics, pharmacodynamics, immunogenicity and related characteristics after infusion.

Conditions

  • Relapsed/Refractory Light Chain Amyloidosis
  • AL Amyloidosis
  • Systemic Light Chain Amyloidosis

Interventions

BIOLOGICAL

Targeted BCMA Autologous CART Cell Injection

Anti-BCMA chimeric antigen receptor autologous T cells are a BCMA-targeted, gene-modified autologous T-cell (CAR-T cell) immunotherapy derived from the participant's autologous peripheral blood mononuclear cells (PBMCs). The cells are transduced with lentivirus generated using a four-plasmid viral packaging system, with the pCDH-BCMA CAR plasmid as the expression vector. The product is administered as an injection by a single intravenous infusion at a dose of 1.0×10\^6 CAR-T cells/kg.

Sponsors & Collaborators

  • Beijing Boren Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2027-12-15
Completion
2029-12-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07626476 on ClinicalTrials.gov