CAR-NK Therapy for Cardiac Amyloidosis

Relapsed/refractory (R/R) light chain cardiac amyloidosis is associated with a poor prognosis, and cellular immunotherapy constitutes a crucial therapeutic modality for these patients. The efficacy and safety of CAR-T therapy have been reported in relevant studies; however, CAR-T manufacturing requires a lengthy timeline, and the leukapheresis procedure places an additional cardiac burden on patients. CAR-NK therapy boasts superior safety profiles compared with CAR-T therapy, and natural killer (NK) cells feature a wide range of sources. Investigators have accumulated prior experience in the clinical application of CAR-NK therapy, and has also achieved the successful development and preclinical application of CD19/BCMA dual-target CAR-T products. Furthermore, in the institution of the Investigator, there are dozens of newly diagnosed and more than 100 follow-up patients with AL cardiac amyloidosis each year. Investigators propose to initiate a phase I/II prospective clinical study to assess the safety and efficacy of umbilical cord blood-derived BCMA/CD19-targeted CAR-NK cell therapy for participants with relapsed/refractory light chain cardiac amyloidosis.

NCT Number	NCT07504289
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Light Chain Cardiac Amyloidosis
Enrollment	36 participants
Start Date	2026-03-07
Primary Completion	2028-03-06 (estimated)
Study Completion	2029-03-06 (estimated)
Updated on ClinicalTrials.gov	2026-03-31