Teclistamab-Daratumumab for AL Amyloidosis

This study is looking at a combination of two drugs, teclistamab and daratumumab, to see if they are safe and effective for people with AL amyloidosis. AL amyloidosis is a condition where abnormal proteins called amyloid build up in organs. Teclistamab works by targeting specific cells (T-cells and plasma cells), and daratumumab targets a protein (CD38) on myeloma cells. The main goal is to see if this combination can lead to a complete blood response (Hematologic Complete Response) within 6 months. You might be able to join if you are 18 years or older. The study aims to reduce harmful proteins in your blood to prevent organ damage, improve organ function, and help you live longer.

Study design
This is an interventional study planning to enroll 25 participants. It is designed to assess the effectiveness and safety of the teclistamab-daratumumab combination.
What's involved
The study treatment is divided into cycles, with each cycle lasting 28 days. The expected duration of study treatment is 6 months.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, Hematologic Complete Response, is measured at 6 months from treatment initiation.

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NCT07110844

Teclistamab-Daratumumab in AL Amyloidosis

Recruiting
PHASE2Ages 18+InterventionalTreatment
Rajshekhar Chakraborty, MD
~25 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:TeclistamabDaratumumab and Hyaluronidase-fihj

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Hematologic Complete Response (Heme-CR) rate
Measured over 6 months from treatment initiation
Amyloid Light-chain Amyloidosis
3 sites across 3 states
Massachusetts1
New York1
Wisconsin1
  • Rajshekhar Chakraborty, MD · PRINCIPAL_INVESTIGATOR · Columbia University

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  • Hematologic Complete Response (Heme-CR) rate6 months from treatment initiation

    Heme-CR will be defined as: involved free light-chain level less than the upper limit of the normal range with negative serum and urine immunofixation; normalization of the uninvolved free light-chain level or free light-chain ratio will not be required to determine a complete response.