Teclistamab-Daratumumab in AL Amyloidosis

Part of paid clinical trials in New York, New York.

Sponsor
Suzanne Lentzsch, MD
Study ID
NCT07110844
Phase
PHASE2
Status
Recruiting
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Conditions

  • Amyloid Light-chain Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2031
Completion
Oct 31, 2033

Study Design

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

Arms

  • Experimental: Teclistamab-Daratumumab
    All participants in this study will receive teclistamab and daratumumab.

Primary Outcome Measure

Hematologic Complete Response (Heme-CR) rate [ Time Frame: 6 months from treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Research Nurse Navigator, RN
[email protected]
646-317-4840
Suzanne Lentzsch, MD, PhD (PRINCIPAL_INVESTIGATOR)
Rajshekhar Chakraborty, MD (SUB_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NY

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