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NCT06292780 · ClinicalTrials.gov registry record · Phase 1
A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)
A Phase 1 study of Relapsed/Refractory Systemic Light Chain Amyloidosis, sponsored by Regeneron Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 220
- Enrollment target
- 18
- Study locations
NCT06292780 is a Phase 1 study of Relapsed/Refractory Systemic Light Chain Amyloidosis that is actively recruiting participants, run by Regeneron Pharmaceuticals. The registered enrollment target is 220 participants. The trial reports 18 study locations across 11 states.
The verdict
NCT06292780, a Phase 1 study of Relapsed/Refractory Systemic Light Chain Amyloidosis, is actively recruiting participants, sponsored by Regeneron Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 220 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvoseltamab will be given to a small number of participants to study the side effects of the study drug and to determine the recommended doses of the study drug to be given to participants in Phase 2. * In Phase 2, linvoseltamab will be given to more participants to continue to assess the side effects of the study drug and to evaluate the ability of linvoseltamab to treat AL amyloidosis. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab have improvement in the abnormal proteins that cause organ problems and for how long * How many participants treated with linvoseltamab have improvement in the heart or kidney and for how long * What the right dosing regimen is for linvoseltamab * What side effects may happen from taking linvoseltamab * How much linvoseltamab is in the blood at different times * Whether the body makes antibodies against linvoseltamab (which could make the drug less effective or could lead to side effects)
Conditions Studied
Interventions
- DRUG Linvoseltamab
Study Locations (18)
Other
- Seoul National University Hospital - Seoul
- Asan Medical Center - Seoul
- Samsung Medical Center - Seoul
- Seoul St. Mary's Hospital - The Catholic University of Korea - Seoul
- Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS) - Barcelona
- University Hospital La Fe - Valencia
- University College London Hospitals - London
- The Christie NHS Foundation Trust - Manchester
California
- City of Hope - Duarte
Colorado
- Colorado Blood Cancer Institute/SCRI - Denver
Michigan
- Karmanos Cancer Institute - Detroit
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
Ohio
- Ohio State University - Columbus
Tennessee
- SCRI Oncology Partners - Nashville
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 220 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2035-02-20 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06292780
The ClinicalTrials.gov registry entry for NCT06292780 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 220 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Relapsed/Refractory Systemic Light Chain Amyloidosis appearing as the primary indexed condition, and to 1 intervention - of which Linvoseltamab is the first listed.
NCT06292780 reports 18 study locations spanning 11 distinct geographic areas - top geographies include Other, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06292780 about?
NCT06292780 is a clinical study titled "A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis)". This study is researching an experimental drug called linvoseltamab ("study drug"). This study is focused on patients who have AL amyloidosis that has returned or have failed other therapies and need to be treated again. The study consists of 2 phases (Phase 1 and Phase 2): * In Phase 1, linvosel...
What is the current status of trial NCT06292780?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 220 participants. The study started on 2024-08-07. Estimated completion is 2035-02-20.
What conditions does trial NCT06292780 study?
This clinical trial studies the following conditions: Relapsed/Refractory Systemic Light Chain Amyloidosis.
What interventions are being tested in trial NCT06292780?
The interventions under investigation include: Linvoseltamab (DRUG).
Who is sponsoring clinical trial NCT06292780?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06292780 being conducted?
This trial has 18 study locations across California, Colorado, Michigan, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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