Who may be eligible for the CAR-NK Therapy for Cardiac Amyloidosis trial?

Inclusion Criteria： 1. Voluntarily participate in this study and sign the informed consent form. 2. Aged 18 to 75 years, of either sex. 3. Pathologically confirmed amyloidosis, with positive Congo red staining of tissue specimens, green birefringent material observed under polarizing microscope, or characteristic electron microscopic findings. 4. Presence of measurable light chain amyloidosis lesions meeting at least one of the following criteria: 1）Serum M-protein ≥ 0.5 g/dL (detected by routine serum protein electrophoresis and immunofixation electrophoresis). 2）Abnormal κ/λ ratio, with the difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg/L. 5\. Confirmed cardiac involvement by amyloidosis, meeting at least one of the following criteria; extramyocardial organ involvement is permitted: 1. Echocardiography: Mean ventricular wall thickness \> 12 mm with no other identifiable cardiac etiologies. 2. Elevated NT-ProBNP level (\> 332 ng/L) without concomitant renal failure or atrial fibrillation. 6\. Having received at least one course of first-line therapy based on bortezomib or CD38 monoclonal antibody with suboptimal hematological response, meeting at least one of the following criteria: 1. Failure to achieve partial response (PR) after 1 treatment cycle. 2. 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. 9\. Sufficient organ function reserve excluding the heart, meeting all the following criteria: 1. Peripheral blood neutrophil count ≥ 1000/μL, hemoglobin ≥ 7 g/dL, platelet count ≥ 50,000/μL; red blood cell or platelet transfusion is permitted within 1 week prior to screening. 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper normal limit (UNL). 3. Serum total bilirubin ≤ 1.5 × UNL. 4. Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m², calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. 5. Baseline oxygen saturation \> 92% in a natural indoor air environment. 10. A prior history of one hematopoietic stem cell transplantation is permitted. 11\. At least 3 weeks have elapsed since the completion of approved therapeutic interventions for AL cardiac amyloidosis (e.g., systemic chemotherapy, immunotherapy) prior to the administration of the study drug. 12\. Female subjects of childbearing potential must have a negative pregnancy test and agree to adopt effective contraceptive measures during the trial period. Exclusion Criteria: 1. NT-ProBNP ≥ 8500 ng/L; 2. Heart failure of New York Heart Association (NYHA) functional class IIIB or IV ; 3. 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; 4. 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; 5. For subjects with congestive heart failure, hospitalization for cardiovascular-related diseases within 4 weeks prior to screening; 6. 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; 7. Supine systolic blood pressure \ 20 mmHg upon standing despite pharmacotherapy (e.g., midodrine, fludrocortisone) and no hypovolemia); 8. A history of hypersensitivity to any component of the cellular product; 9. A history of other malignant neoplasms; 10. Receipt of BCMA-targeted therapy, including antibody-drug conjugates (ADCs), bispecific antibodies, and cellular therapy, within 3 months prior to screening; 11. Receipt of gene therapy within 3 months prior to screening; 12. Active infections requiring treatment (excluding uncomplicated urinary tract infections and bacterial pharyngitis); prophylactic antibiotic, antiviral, and antifungal therapy is permitted, however; 13. 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; 14. Unresolved toxicities from prior antineoplastic therapy (toxicities per CTCAE Version 5.0 not recovered to ≤ Grade 1, except for fatigue, anorexia, and alopecia); 15. Subjects with a history of epilepsy or other central nervous system diseases; 16. Lactating women who are unwilling to discontinue breastfeeding; 17. Any other condition that the investigator deems may increase the risk to the subject or interfere with the trial results.

ClinicalTrials.gov record NCT07504289

CAR-NK Therapy for Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

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

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 1/2A study that combines safety and dose-finding (phase 1) with a first look at whether the treatment has an effect (phase 2).

Age18 years old to 75 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase I/II interventional study evaluates an umbilical cord blood–derived CAR‑NK cell infusion that targets BCMA and CD19 in adults with relapsed or refractory light‑chain cardiac amyloidosis. Participants receive the CAR‑NK treatment in a single-group, open-label design and are monitored for safety and disease measures. Early follow-up visits occur frequently in the first month, then monthly in year one and every three months in year two.

What it is studying. The study is testing the safety (including treatment-emergent adverse events and any dose-limiting toxicities within 28 days) and the anti-disease activity of umbilical cord blood–derived BCMA/CD19-targeted CAR‑NK cells in relapsed/refractory light‑chain cardiac amyloidosis. Assessments include blood tests of light chains and immune markers, cardiac biomarkers and imaging, and response evaluation using LYRIC criteria; peripheral blood will be checked for CAR expansion.

What the researchers hope to learn. To determine the safety profile and dose-limiting toxicities of cord blood–derived BCMA/CD19 CAR‑NK cells; to collect data on treatment activity using clinical assessments, blood and cardiac biomarkers, and LYRIC response criteria; and to measure CAR‑NK cell expansion and related immune changes.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure: CAR-NK

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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:
1）Serum M-protein ≥ 0.5 g/dL (detected by routine serum protein electrophoresis and immunofixation electrophoresis).
2）Abnormal κ/λ ratio, with the difference between involved and uninvolved free light chains (dFLC) ≥ 50 mg/L.
Confirmed cardiac involvement by amyloidosis, meeting at least one of the following criteria; extramyocardial organ involvement is permitted:
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.
Having received at least one course of first-line therapy based on bortezomib or CD38 monoclonal antibody with suboptimal hematological response, meeting at least one of the following criteria:
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.
Sufficient organ function reserve excluding the heart, meeting all the following criteria:
Peripheral blood neutrophil count ≥ 1000/μL, hemoglobin ≥ 7 g/dL, platelet count ≥ 50,000/μL; red blood cell or platelet transfusion is permitted within 1 week prior to screening.
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper normal limit (UNL).
Serum total bilirubin ≤ 1.5 × UNL.
Estimated glomerular filtration rate (eGFR) ≥ 20 mL/min/1.73 m², calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Baseline oxygen saturation > 92% in a natural indoor air environment. 10. A prior history of one hematopoietic stem cell transplantation is permitted.
At least 3 weeks have elapsed since the completion of approved therapeutic interventions for AL cardiac amyloidosis (e.g., systemic chemotherapy, immunotherapy) prior to the administration of the study drug.
Female subjects of childbearing potential must have a negative pregnancy test and agree to adopt effective contraceptive measures during the trial period.

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;
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.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will receive an infusion of umbilical cord blood‑derived BCMA/CD19 CAR‑NK cells (study product) on Day 0 and undergo close safety monitoring, especially during the first 28 days. Study visits include frequent early follow‑ups (Days 1, 4, 7, 10, 14, 21, 28), then monthly for the first year and every 3 months in the second year; assessments include blood draws for safety labs, CAR/immune/cytokine measurements, cardiac biomarkers, ECGs and echocardiography, and disease tests (immunofixation, free light chains). Women of childbearing potential will have pregnancy testing and must agree to effective contraception; lactating women must agree to stop breastfeeding. The study team will monitor and record adverse events and laboratory abnormalities throughout follow‑up.

How the study is structured. Interventional Phase I/II, open-label, single-group study. All enrolled participants receive the CAR‑NK cell infusion (no randomization or placebo). Intensive safety and laboratory monitoring occurs in the first 28 days, with monthly assessments during the first year and quarterly visits in the second year.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The registry lists this study under Light Chain Cardiac Amyloidosis. Does it apply to my diagnosis?
This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Mar 7, 2026 (estimated)
Primary completion: Mar 6, 2028 (estimated)
Study completion: Mar 6, 2029 (estimated)
Target enrollment: 36 participants (estimated)
Last updated on registry: Mar 31, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal investigator: Yang Xu, professor
Second Affiliated Hospital, School of Medicine, Zhejiang University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Yang Xu 📞 0571-87783679 ✉ yxu@zju.edu.cn

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Relapsed/refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
CAR-T: A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent form: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
difference between involved and uninvolved free light chains: The difference between the abnormal ('involved') and normal ('uninvolved') free light chain levels in the blood. Used in some conditions to decide whether disease is measurable and to track response.
Echocardiography: An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
very good partial response: A response category used in some blood conditions meaning the disease marker has fallen a great deal but not disappeared. The exact definition depends on the condition and the study.
overall survival: The length of time from the start of the study or treatment that participants are alive, whatever the cause of death.
ECOG: A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
neutrophil count: The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
prior to screening: The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Estimated glomerular filtration rate: A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
Baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
study drug: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
childbearing potential: Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
QTcF: A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
bispecific: An engineered antibody that attaches to two targets at once, often linking an immune cell to a diseased cell so the immune cell can attack it.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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