AL Amyloidosis (AL)Phase 2NCT07335887
Sonrotoclax Plus Dexamethasone With or Without Daratumumab Regimen in Patients With t(11;14) Primary AL Amyloidosis
A Phase 2 study testing sonrotoclax, Daratumumab and Dexamethasone in people with AL Amyloidosis (AL) and t(11;14) Positive, run by Peking University People's Hospital at 3 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AL Amyloidosis (AL), t(11;14) Positive
- What is being tested?
- sonrotoclax, Daratumumab and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 3 sitesChina
- Study dates
- 10 Feb 2026to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Peking University First Hospital
Beijing
Fude Zhou, +86 13501162527, zhoufude1801@vip.sina.com
- Recruiting
Peking University People's Hospital
Beijing
Yang Liu, +86 13716926210, pkuphliuyang@bjmu.edu.cn
- Not yet recruiting
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Pengcheng He, +86 18991232609, hepc@163.com
About this study
Official title: An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis
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.
Read the detailed description
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.
- Conditions
- AL Amyloidosis (AL), t(11;14) Positive
- Being tested
- sonrotoclax, Daratumumab, Dexamethasone
- Keywords
- sonrotoclax, AL amyloidosis, t(11;14), BCL-2i
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sonrotoclaxDrug
Also called BGB-11417
cohor A \& Cohort B:
Induction therapy (C1-4) : Sonrotoclax once daily
A conventional 3+3 design will determine the target sonrotoclax dose during the C1 safety run-in phase. And dose-limiting toxicity (DLT) assessed during a 28-day evaluation window. Patients who are enrolled after the safety run-in phase will receive sonrotoclax at the dose determined in safety run-in phase.
A 3-day ramp-up is used (320 mg: 80→160→320 mg on D1-D3; 640 mg: 160→320→640 mg on D1-D3) in C1, with the Day 3 dose maintained from Day 4 onward for all patients.
Subsequent therapy (C5-12)
Sonrotoclax once daily (same dose as in the induction phase)
DaratumumabDrug
Cohor A Only
Daratumumab (16 mg/kg intravenously) or daratumumab and hyaluronidase-fihj (1800 mg subcutaneously）once weekly C1-2; every two weeks C3-6; every month C7-12
DexamethasoneDrug
cohor A \& Cohort B:
Dexamethasone (40 mg, once weekly) for 12 cycles. The dose was halved for patients 75 years of age or older, and in patients who were intolerant of dexamethasone, as judged by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Sond±D | Experimental | Cohort A: (sample size 20) sonrotoclax combined with daratumumab and dexamethasone in t(11;14) AL amyloidosis, newly diagnosed or previously untreated with anti-CD38 mAb therapy.
Cohort B: (sample size 19) sonrotoclax combined with dexamethasone in t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy
All patients will receive up to 12 cycles therapy until major organ deterioration (MOD)-progression free survival (PFS) event, death, withdrawal of informed consent, need for alternative therapy, intolerance, or study termination, whichever occurs first.
Transplant-eligible patients could undergo stem cell collection during induction; autologous transplantation was permitted after completion of the primary endpoint assessment (after cycle 4) at investigator discretion Receives: Drug: sonrotoclax; Drug: Daratumumab; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematological ≥VGPR rate within four cycles of induction therapy
Defined as the proportion of patients achieving VGPR, or CR within four cycles of therapy
Measured: At the end of Cycle 4 (each cycle is 28 days)
Secondary outcomes (14)
Hematological ORR after four cycles of therapy
Defined as the proportion of patients achieving PR,VGPR, or CR at the end of four cycles of therapy
Measured: At the end of Cycle 4 (each cycle is 28 days)
Hematological CR rate at the end of four cycles of therapy
Defined as the proportion of patients achieving CR at the end of four cycles of therapy
Measured: at the end of 4 cycles of therapy (each cycle is 28 days)
Cardiac response rate at the end of 6 cycles of treatment
Defined as the proportion of patients achieving Cardiac response at the end of 6 cycles of therapy
Measured: At the end of Cycle 6 (each cycle is 28 days)
Hepatic response rate at the end of 6 cycles of treatment
Defined as the proportion of patients achieving Hepatic response at the end of 6 cycles of therapy
Measured: At the end of Cycle 6 (each cycle is 28 days)
Renal response rate at the end of 6 cycles of treatment
Defined as the proportion of patients achieving Hepatic response at the end of 6 cycles of therapy
Measured: At the end of 6 cycles of treatment (each cycle is 28 days)
1-year MOD-PFS rate
Defined as the proportion of patients in the safety analysis set who have not experienced a MOD-PFS event within 1 year after treatment. MOD-PFS is defined as the time from treatment initiation to the occurrence of any of the following events (whichever comes first): end-stage heart disease (requiring heart transplantation, left ventricular assist device, or intra-aortic balloon pump), end-stage renal disease (requiring dialysis or renal transplantation), hematological progression, or death
Measured: 1 year
1-year PFS rate
Defined as the proportion of patients in the safety analysis set who are alive and free from hematological progression at 1 year after treatment. PFS is defined as the time from treatment initiation to hematological progression or death (whichever occurs first)
Measured: 1 year
1-year OS rate
Defined as the proportion of patients in the safety analysis set who are alive at 1 year after treatment
Measured: 1 year
Time to Response (TTR)
Defined as the time from treatment initiation to the first hematological efficacy assessment achieving PR.
Measured: 1 year
Time to VGPR
Defined as the time from treatment initiation to the first hematological efficacy assessment achieving VGPR
Measured: 1 year
Time to Cardiac Response
Defined as the time from treatment initiation to the first cardiac efficacy assessment achieving response.
Measured: 1 year
Time to Renal Response
Defined as the time from treatment initiation to the first renal efficacy assessment achieving response
Measured: 1 year
Time to Hepatic Response
Defined as the time from treatment initiation to the first hepatic efficacy assessment achieving response.
Measured: 1 year
Adverse Events (AEs), Serious Adverse Events (SAEs), and laboratory abnormalities
the proportion of patients with Adverse Events (AEs), Serious Adverse Events (SAEs), and laboratory abnormalities after therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start10 Feb 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL Amyloidosis (AL)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Lu, MD, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07335887
- Sponsor's protocol ID
- 2025PHD030-002
- Status last verified
- Jul 2026
- First submitted
- 14 Dec 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optimized Treatment for Patients With Primary Systemic Light Chain Amyloidosis
- ClinicalTrials.gov ID
- NCT07335887
- Acronym / sponsor ID
- 2025PHD030-002
- Conditions
- AL Amyloidosis (AL), t(11;14) Positive
- Keywords
- sonrotoclax, AL amyloidosis, t(11;14), BCL-2i
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sond±D | Experimental | Drug: sonrotoclax, Drug: Daratumumab, Drug: DexamethasoneCohort A: (sample size 20) sonrotoclax combined with daratumumab and dexamethasone in t(11;14) AL amyloidosis, newly diagnosed or previously untreated with anti-CD38 mAb therapy. Cohort B: (sample size 19) sonrotoclax combined with dexamethasone in t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy All patients will receive up to 12 cycles therapy until major organ deterioration (MOD)-progression free survival (PFS) event, death, withdrawal of informed consent, need for alternative therapy, intolerance, or study termination, whichever occurs first. Transplant-eligible patients could undergo stem cell collection during induction; autologous transplantation was permitted after completion of the primary endpoint assessment (after cycle 4) at investigator discretion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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:
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sonrotoclaxAlso: BGB-11417cohor A \& Cohort B: Induction therapy (C1-4) : Sonrotoclax once daily A conventional 3+3 design will determine the target sonrotoclax dose during the C1 safety run-in phase. And dose-limiting toxicity (DLT) assessed during a 28-day evaluation window. Patients who are enrolled after the safety run-in phase will receive sonrotoclax at the dose determined in safety run-in phase. A 3-day ramp-up is used (320 mg: 80→160→320 mg on D1-D3; 640 mg: 160→320→640 mg on D1-D3) in C1, with the Day 3 dose maintained from Day 4 onward for all patients. Subsequent therapy (C5-12) Sonrotoclax once daily (same dose as in the induction phase) | Drug | Sond±D |
| DaratumumabCohor A Only Daratumumab (16 mg/kg intravenously) or daratumumab and hyaluronidase-fihj (1800 mg subcutaneously）once weekly C1-2; every two weeks C3-6; every month C7-12 | Drug | Sond±D |
| Dexamethasonecohor A \& Cohort B: Dexamethasone (40 mg, once weekly) for 12 cycles. The dose was halved for patients 75 years of age or older, and in patients who were intolerant of dexamethasone, as judged by the investigators. | Drug | Sond±D |
Primary outcome
hematological ≥VGPR rate within four cycles of induction therapy
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Defined as the proportion of patients achieving VGPR, or CR within four cycles of therapy
14 secondary outcomes
Hematological ORR after four cycles of therapy
Time frame: At the end of Cycle 4 (each cycle is 28 days)
Hematological CR rate at the end of four cycles of therapy
Time frame: at the end of 4 cycles of therapy (each cycle is 28 days)
Cardiac response rate at the end of 6 cycles of treatment
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Hepatic response rate at the end of 6 cycles of treatment
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Renal response rate at the end of 6 cycles of treatment
Time frame: At the end of 6 cycles of treatment (each cycle is 28 days)
1-year MOD-PFS rate
Time frame: 1 year
1-year PFS rate
Time frame: 1 year
1-year OS rate
Time frame: 1 year
Time to Response (TTR)
Time frame: 1 year
Time to VGPR
Time frame: 1 year
Time to Cardiac Response
Time frame: 1 year
Time to Renal Response
Time frame: 1 year
Time to Hepatic Response
Time frame: 1 year
Adverse Events (AEs), Serious Adverse Events (SAEs), and laboratory abnormalities
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sonrotoclax, Daratumumab and Dexamethasone in people with AL Amyloidosis (AL) and t(11;14) Positive, run by Peking University People's Hospital at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Liu (+86 13716926210, pkuphliuyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hematological ≥VGPR rate within four cycles of induction therapy (time frame: At the end of Cycle 4 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.