NCT07504289

CAR-NK Therapy for Cardiac Amyloidosis

Clinical Study of CAR-NK Cells Targeting BCMA/CD19 in the Treatment of Refractory/Relapsed Light-Chain Cardiac Amyloidosis

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Light Chain Cardiac Amyloidosis

Interventions

Type	Name	Description
PROCEDURE	CAR-NK	R/R AL cardiac amyloidosis patients in the CD19/BCMA dual-target CAR-NK therapy arm

Timeline

• Start date: 2026-03-07
• Primary completion: 2028-03-06
• Completion: 2029-03-06
• First posted: 2026-03-31
• Last updated: 2026-03-31