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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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;