Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11… (NCT07687004) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Sonrotoclax and BCMA Bispecific Antibody in Newly Diagnosed Systemic AL Amyloidosis Based on t(11;14) Genetic Stratification
China50 participantsStarted 2026-08-01
Plain-language summary
This study is a prospective, single-center, phase Ib/II clinical trial designed to evaluate the tolerability of sonrotoclax plus dexamethasone in this phase Ib/II umbrella study and to determine the recommended phase II dose (RP2D). It also aims to assess the safety and hematologic response rate of sonrotoclax plus dexamethasone in patients with newly diagnosed systemic light-chain amyloidosis (NDAL) harboring t(11;14), and of a BCMA/CD3 bispecific antibody in patients with NDAL without t(11;14). In addition, this study seeks to explore a chemotherapy-free treatment strategy based on t(11;14)-guided genetic stratification.
Who can participate
Age range
18 Years – 70 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
. Subjects entering the phase Ib dose-escalation stage must also have confirmed t(11;14) translocation by FISH or other genetic testing.
Exclusion criteria
. Unstable angina, symptomatic myocardial ischemia, myocardial infarction, or coronary revascularization within 180 days before the first dose;
. NT-proBNP \>8500 ng/L;
. Congestive heart failure with hospitalization for cardiovascular disease within 4 weeks before randomization;
. Heart failure judged by the investigator to be caused by ischemic heart disease, such as prior myocardial infarction with elevated cardiac enzymes and electrocardiographic changes, or uncorrected valvular disease, rather than AL amyloid cardiomyopathy;
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
Phase 1b: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timeframe: Up to 28 days
2
Phase 1b and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Adverse Events Leading to Discontinuation, and Adverse Events of Special Interest (AESIs).
Timeframe: Up to 30 days after the last dose of the study drug
3
Phase 2: Rate of Hematologic Very Good Partial Response (VGPR) or Better
Timeframe: 6 months
Trial details
NCT IDNCT07687004
SponsorInstitute of Hematology & Blood Diseases Hospital, China
. History of sustained ventricular tachycardia or ventricular fibrillation, or history of atrioventricular (AV) node or sinoatrial (SA) node dysfunction requiring a pacemaker or implantable cardioverter-defibrillator (ICD) but without implantation. Patients with an implanted pacemaker or ICD may be enrolled;
. Corrected QT interval using Fridericia's formula (QTcF) \>500 msec. Patients with an implanted pacemaker may be enrolled regardless of the corrected QT interval result;
. Supine systolic blood pressure \<90 mmHg;
. Any other cardiovascular or cerebrovascular disease that, in the investigator's judgment, makes the subject unsuitable for participation in this study.