CAR-NK Therapy for Cardiac Amyloidosis
Starting soon · Phase 1/Phase 2
Conditions studied: Light Chain Cardiac Amyloidosis
In brief
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.
Key facts
- Study ID
- NCT07504289
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 36
- Starts
- 2026-03-07
- Expected to finish
- 2029-03-06
- Last updated by the study team
- 2026-03-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- NT-ProBNP ≥ 8500 ng/L;
- Heart failure of New York Heart Association (NYHA) functional class IIIB or IV ;
- Heart failure judged by the investigator to be caused by ischemic heart disease (e.g., a previous myocardial infarction with documented elevated cardiac enzymes and electrocardiographic changes) or uncorrected valvular heart disease, rather than primarily by AL amyloidosis;
- Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or percutaneous coronary intervention with recent stent implantation within 6 months, or coronary artery bypass grafting within 6 months;
- For subjects with congestive heart failure, hospitalization for cardiovascular-related diseases within 4 weeks prior to screening;
- Baseline corrected QT interval by Fridericia's formula (QTcF) > 500 milliseconds on a 12-lead electrocardiogram at screening. Subjects with a permanent pacemaker implanted may be enrolled regardless of their calculated QTc interval;
- Supine systolic blood pressure < 90 mmHg, or symptomatic orthostatic hypotension (defined as a decrease in systolic blood pressure > 20 mmHg upon standing despite pharmacotherapy (e.g., midodrine, fludrocortisone) and no hypovolemia);
- A history of hypersensitivity to any component of the cellular product;
- A history of other malignant neoplasms;
- Receipt of BCMA-targeted therapy, including antibody-drug conjugates (ADCs), bispecific antibodies, and cellular therapy, within 3 months prior to screening;
- Receipt of gene therapy within 3 months prior to screening;
- Active infections requiring treatment (excluding uncomplicated urinary tract infections and bacterial pharyngitis); prophylactic antibiotic, antiviral, and antifungal therapy is permitted, however;
- Subjects infected with hepatitis B (HBsAg-positive with HBV-DNA < 10³ copies/mL is not an exclusion criterion) or hepatitis C virus (including virus carriers), syphilis, and other acquired or congenital immunodeficiency diseases, including but not limited to human immunodeficiency virus (HIV) infection;
- Unresolved toxicities from prior antineoplastic therapy (toxicities per CTCAE Version 5.0 not recovered to ≤ Grade 1, except for fatigue, anorexia, and alopecia);
- Subjects with a history of epilepsy or other central nervous system diseases;
- Lactating women who are unwilling to discontinue breastfeeding;
- Any other condition that the investigator deems may increase the risk to the subject or interfere with the trial results.
Full record on ClinicalTrials.gov
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