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

Conditions

• AL Amyloidosis (AL)
• t(11;14) Positive

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sonrotoclax — DRUG
  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)
• Daratumumab — DRUG
  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
• Dexamethasone — DRUG
  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 Details

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.

Key Dates

First listed

Jan 13, 2026

Start date

Feb 10, 2026

Status verified

Jul 2026

Primary completion

Dec 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

39 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sond±D
  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

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) ]

Central Contacts

• Yang Liu
  +86 13716926210
  [email protected]