ClinicalTrials.gov record NCT07335887

Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis

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

An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
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 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationChina
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 2 interventional study tests sonrotoclax combined with dexamethasone, with or without daratumumab, in people who have t(11;14) primary AL amyloidosis. Treatment is given in up to 12 cycles; the main measure is best hematologic response (≥VGPR) within four cycles. Participants are also assessed for organ responses, survival outcomes, and safety. The study includes cohorts for patients newly untreated with anti‑CD38 therapy and for those who are relapsed/insensitive to prior anti‑CD38 therapy.

What it is studying. The study is testing whether a regimen containing sonrotoclax and dexamethasone, with or without daratumumab, produces hematologic responses and organ responses and what its safety profile is in people with t(11;14) AL amyloidosis.

What the researchers hope to learn. To evaluate the efficacy (hematologic and organ responses) and safety of sonrotoclax plus dexamethasone with or without daratumumab in t(11;14) AL amyloidosis; secondary goals include rates of CR/PR/VGPR, cardiac/renal/hepatic responses, 1-year PFS and OS, time-to-response measures, adverse events, and correlation of minimal residual disease (MRD) status with outcomes.

What this study is about

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

The goal of this study is to evaluate the efficacy and safety of Sonrotoclax combined Regimen in patients with t(11;14) AL amyloidosis. Participants will receive the Sonrotoclax Plus Dexamethasone regimen with or without Daratumumab for 12 cycles. The Hematologic Response, Organ Response, Survival, and Safety will be evaluated.

Interventions being studied

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

Drug
  • sonrotoclax
  • Daratumumab
  • Dexamethasone

Eligibility

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

Inclusion criteria

  • Patients who meet the diagnostic criteria for Primary Systemic Light Chain Amyloidosis (according to the Systemic Light Chain Amyloidosis Diagnosis and Treatment Guidelines (2021 Revision)).
  • Age ≥ 18 years.
  • Confirmed FISH test result of t(11;14) positive by each center or a third-party laboratory, or a prior FISH test report indicating t(11;14) positivity
  • ECOG Performance Status score of 0-2.
  • Presence of measurable disease, defined by at least one of the following criteria:
  • Serum M-protein ≥ 0.5 g/dL
  • Serum free light chain (FLC) level ≥ 40 mg/L with an abnormal kappa/lambda ratio.
  • Adequate organ function, defined as:
  • Hemoglobin (HGB) > 80 g/L
  • Platelet count > 50 × 10⁹/L
  • Absolute neutrophil count (ANC) > 1.0 × 10⁹/L
  • Total bilirubin ≤ 2.0 × ULN; AST and ALT ≤ 3.0 × ULN
  • Creatinine clearance (CrCl) ≥ 30 mL/min
  • Oxygen saturation ≥ 90%
  • Life expectancy greater than 6 months.
  • Patient understands and voluntarily signs an informed consent form (ICF).
  • Cohort Assignment:
  • Cohort A: Includes patients who are newly diagnosed or have not been previously exposed to anti-CD38 monoclonal antibody therapy.
  • Cohort B: Includes patients who are insensitive to or have relapsed after anti-CD38 monoclonal antibody therapy.Insensitivity to anti-CD38 monoclonal antibody therapy is defined as failure to achieve at least a Partial Response (PR) after 1 cycle, or failure to achieve at least a Very Good Partial Response (VGPR) after 3 cycles of an anti-CD38-containing regimen.

Exclusion criteria

  • Meets the diagnostic criteria for active multiple myeloma or active lymphoplasmacytic lymphoma
  • Presence of other malignancies at an advanced stage with systemic metastases.
  • IgM-type AL amyloidosis.
  • Prior treatment with a BCL-2 inhibitor (BCL-2i).
  • Presence of any of the following severe cardiovascular diseases
  • Mayo 2004 stage IIIb: NT-proBNP >8500 ng/L.
  • NYHA class IIIb-IV
  • Left ventricular ejection fraction (LVEF) <40%.
  • QT interval corrected by Fridericia's formula (QTcF) >480 ms
  • Investigator assessment that heart failure is due to ischemic heart disease (e.g., prior history of myocardial infarction with elevated cardiac enzymes and ECG changes) or uncorrected valvular disease, rather than primarily caused by AL amyloidosis.
  • Hospitalization for unstable angina or myocardial infarction within 6 months prior to the first dose, or cardiac interventional therapy or coronary artery bypass grafting within 6 months.
  • For patients with congestive heart failure, hospitalization for cardiovascular disease within 4 weeks prior to Cycle 1 Day 1.
  • History of sustained ventricular tachycardia or aborted ventricular fibrillation, or history of atrioventricular node or sinus node dysfunction requiring a pacemaker/implantable cardioverter-defibrillator (ICD) but not implanted.
  • Severe or persistent infection that is not effectively controlled. (Acute infection requiring antibacterial, antifungal, or antiviral therapy that has not resolved within 14 days prior to dosing).
  • Positive status for human immunodeficiency virus (HIV) antibody (HIVAb).
  • Serological status reflecting active viral hepatitis B (HBV) or hepatitis C (HCV) infection, as follows:
  • Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Patients who are positive for HBcAb but negative for HBsAg are eligible if HBV DNA is undetectable and they are willing to undergo monthly monitoring for HBV reactivation.
  • Positive for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible if HCV RNA is undetectable.
  • Patients receiving renal replacement therapy.
  • Patients with known hypersensitivity to any component of the investigational regimen.
  • Any condition that, in the investigator's judgment, would increase the risk to the subject or affect the study results.
  • Patients with AL amyloidosis currently participating in other investigational drug clinical studies.
  • Patients who are pregnant, breastfeeding, or planning to become pregnant during the study participation.
  • Patients who are receiving any moderate or strong CYP3A4 inhibitors (within ≤7 days or 5 half-lives, whichever is shorter) or strong CYP3A4 inducers (within ≤14 days or 5 half-lives, whichever is shorter) prior to the first dose of the study drug; or patients who require continuous treatment with moderate or strong CYP3A inhibitors or strong CYP3A inducers

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

Treatment options for AL amyloidosis are limited. Before the approval of daratumumab, newly diagnosed light-chain amyloidosis was often managed with anti-myeloma regimens such as bortezomib. For patients with relapsed/refractory (R/R) disease, there is currently a lack of standard treatment options both domestically and internationally. Guidelines recommend enrollment in clinical trials or the use of regimens containing previously unexposed agents, such as bortezomib or daratumumab. Based on preliminary data of BCL-2 inhibitors in t(11;14) amyloidosis, this study aims to explore the efficacy and safety of sonrotoclax and dexamethasone with or without Daratumumab. Newly diagnosed patients with t（11;14）will receive the combination of sonrotoclax, daratumumab, and dexamethasone. t(11;14) Patients with relapsed/refractory AL amyloidosis (RRAL) will be treated with sonrotoclax plus dexamethasone. For transplant-eligible patients, stem cell collection is permitted during the induction phase of therapy. The timing of ASCT may be assessed after the primary endpoint evaluation (completion of 4 treatment cycles) and determined by the investigator.

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 receive sonrotoclax plus dexamethasone for up to 12 treatment cycles (each cycle is 28 days); some people also receive daratumumab (given by IV or subcutaneous dosing on a schedule described in the protocol). Expect regular clinic visits for drug administration (for daratumumab), daily oral dosing (sonrotoclax), weekly dexamethasone, safety checks, blood tests to measure hematologic and organ responses, and monitoring for adverse effects. Stem‑cell collection is permitted during the induction phase and the timing of autologous stem cell transplant may be considered after the first four cycles. Pregnancy and breastfeeding are not allowed during participation, and additional monitoring (for example for hepatitis B reactivation) is required in specific situations per the protocol.

How the study is structured. Phase 2, open-label, single-group interventional study. Participants receive sonrotoclax once daily plus weekly dexamethasone for up to 12 cycles; daratumumab is added in the cohort for patients who are newly diagnosed or not previously exposed to anti‑CD38 therapy. The primary outcome is best hematologic ≥VGPR within four 28-day cycles; multiple secondary outcomes measure organ responses, survival, and adverse events.

Questions you could ask

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

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on AL amyloidosis

Clinical trials69 trials listed for AL amyloidosisEvery trial the registry lists for AL amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in AL amyloidosis researchLatest monthly update: September 2026. Includes: Daratumumab alone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 10, 2026
Primary completion
Dec 31, 2027 (estimated)
Study completion
Aug 31, 2028 (estimated)
Target enrollment
39 participants (estimated)
Last updated on registry
Jul 28, 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
Peking University People's Hospital
Principal investigator
Jin Lu, MD, chief physician
Peking University People's Hospital

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.

Participating sites (3)

Terms used on this page · explanations by MedicalUpdates.ai

ECOG Performance Status
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.
Serum free light chain
Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
Absolute 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.
× ULN
The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
Creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
Life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
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.
Cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
relapsed
A condition that improved with treatment and has since returned or worsened.
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.
Prior treatment
Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
QTcF
A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
investigational
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.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
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.
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.
standard treatment
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
enrollment
The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
ASCT
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
primary endpoint
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.

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.

← Back to clinical trials