NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Suzanne Lentzsch, MD · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.

Detailed description

The purpose of this study is to assess the effectiveness and safety of teclistamab-daratumumab combination in newly diagnosed AL amyloidosis. The study aims to evaluate whether this combination is able to effectively decrease the level of toxic amyloid-producing light chains circulating in the participants' blood, with the overarching goal of avoiding organ damage, improving organ function, and prolonging life.

Conditions

• Amyloid Light-chain Amyloidosis

Interventions

Type	Name	Description
DRUG	Teclistamab	Teclistamab is a T-cell redirecting bispecific antibody (BsAb) targeting CD3 on T-cells and B-cell maturation antigen (BCMA) on plasma cells.
DRUG	Daratumumab and Hyaluronidase-fihj	Daratumumab is an monoclonal antibody that targets the CD38 protein on the surface of myeloma cells.

Timeline

• Start date: 2025-11-07
• Primary completion: 2031-10-01
• Completion: 2033-10-01
• First posted: 2025-08-08
• Last updated: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study