Systemic light-chain (AL) amyloidosis is a plasma cell disorder characterized by the production of misfolded immunoglobulin light chains that deposit in organs and lead to progressive organ dysfunction. Although daratumumab-based therapy has improved outcomes, a substantial proportion of patients fail to achieve deep hematologic responses.
This is a prospective, single-arm, single-center clinical study evaluating the safety and efficacy of the BCMA/GPRC5D/CD3 trispecific antibody QLS4131 in patients with newly diagnosed systemic AL amyloidosis.
Voluntarily provide written informed consent (ICF) prior to any study-specific procedures.
Age ≥18 years, regardless of sex.
Newly diagnosed primary systemic light-chain (AL) amyloidosis.
Difference between involved and uninvolved serum free light chains (dFLC) ≥20 mg/L; and
Non-AL amyloidosis, including hereditary amyloidosis or any other non-AL subtype.
Symptomatic multiple myeloma.
Grade >2 peripheral neuropathy or Grade ≥2 painful peripheral neuropathy at screening, regardless of current treatment.
History of another malignancy within 5 years before enrollment, except AL amyloidosis.