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AL-003NCT07151690

BCMA/CD3 Bispecific Antibody Treatment for Newly Diagnosed Amyloidosis

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 4 versions: 3 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Secondary endpoints revised (8)v3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Enrollment target: 10 to 21
    • Eligibility criteria shortened, about 506 words
    • Start date changed from estimate of Aug 27, 2025 to Sep 4, 2025
    • Secondary endpoints: details revised at 2 of 8 entries
    • Site details revised
  3. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Rate of Hematologic Very Good Partial Response (VGPR) or Better
Timeframe: 4 months
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the first dose through 30 days after the last dose, up to approximately 24 months.

Secondary (8)

Time to First Hematologic Response (TTR)
Best Hematologic Response Achieved
Duration of Hematologic Response (DOR)
Overall Response Rate (ORR)
Progression-Free Survival (PFS)
Show 3 moreShow less
Overall Survival (OS)
Minimal Residual Disease (MRD) Negativity Rate
Organ Response

Arms and interventions

BsAbs-treatment groupExperimental

Treatment involves a 12-cycle course of weekly subcutaneous CM336, with step-up dosing during the first week (3 mg on Day 1, 20 mg on Day 4, and 40 mg weekly from Day 8 onward). Dose frequency may be reduced to every two weeks in patients achieving ≥VGPR after 4 cycles.

Drugs: anti-BCMA/CD3 bispecific antibody

Sites

1 site in 1 country

  • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical SciencesTianjin, China