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

Sponsor
Peking University People's Hospital
Study ID
NCT07335887
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sonrotoclax — DRUG
    t(11;14) AL amyloidosis Newly diagnosed or previously untreated with anti-CD38 mAb therapy Induction therapy (C1-4) Sonrotoclax once daily ( dose depends on the 3+3 study design during safety run-in period in C1) Consolidation therapy (C5-12) Sonrotoclax once daily (same as the target dose in induction therapy) t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy Induction therapy (C1-4) Sonrotoclax once daily (dose depends on the 3+3 study design during safety run-in period in C1) Consolidation therapy (C5-12) Sonrotoclax once daily (same as the target dose in induction therapy)
  • Daratumumab — DRUG
    t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy Daratumumab (16 mg/kg intravenously or 1800 mg subcutaneously, once weekly C1-2; every two weeks C3-6; every month C7-12)
  • Dexamethasone — DRUG
    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

Start date
Jan 1, 2026
Status verified
Dec 2025
Primary completion
Feb 29, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
39 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sond±D
    Cohort A: sonrotoclax combined with daratumumab and dexamethasone in t(11;14) AL amyloidosis, newly diagnosed or previously untreated with anti-CD38 mAb therapy. Cohort B: sonrotoclax combined with daratumumab and dexamethasone in t(11;14) AL patients insensitive to or relapsed after anti-CD38 mAb therapy

Primary Outcome Measure

Best hematological ≥VGPR rate within four cycles of therapy [ Time Frame: At the end of Cycle 4 (each cycle is 28 days) ]