CAR-NK Therapy for Cardiac Amyloidosis (NCT07504289) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
CAR-NK Therapy for Cardiac Amyloidosis
36 participantsStarted 2026-03-07
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Voluntarily participate in this study and sign the informed consent form.
✓. Aged 18 to 75 years, of either sex.
✓. Pathologically confirmed amyloidosis, with positive Congo red staining of tissue specimens, green birefringent material observed under polarizing microscope, or characteristic electron microscopic findings.
✓. Presence of measurable light chain amyloidosis lesions meeting at least one of the following criteria:
✓. Echocardiography: Mean ventricular wall thickness \> 12 mm with no other identifiable cardiac etiologies.
✓. Elevated NT-ProBNP level (\> 332 ng/L) without concomitant renal failure or atrial fibrillation.
✓. Failure to achieve partial response (PR) after 1 treatment cycle.
✓. Failure to achieve very good partial response (VGPR) after 2 treatment cycles. 7. Estimated overall survival ≥ 12 weeks. 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3.
Exclusion criteria
What they're measuring
1
safty and efficacy
Timeframe: Starting on Day 0 (CB CAR-NK-BCMA/CD19 infusion), participants will return to the outpatient clinic at the following intervals:• Days 1, 4, 7, 10, 14, 21, 28• Month 2 (±1 week)• Month 3 (±1 week)
2
the safety and efficacy of umbilical cord blood-derived CAR-NK cells targeting BCMA/CD19 (CB CAR-NK-BCMA/CD19) in the treatment of patients with light chain cardiac amyloidosis
Timeframe: 1.Follow-up visits will be conducted on Days 1, 4, 7, 10, 14, 21, and 28 post-infusion (treatment phase). 2. Within the first year: Assessments will be performed once monthly From Year 1 to Year 2: Assessments will be performed once every 3 months
Trial details
NCT IDNCT07504289
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
✕. 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;