NCT07524634

Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis

Dose Schedule Investigation of B-Cell Maturation Antigen (BCMA) Bispecific Antibody, Elranatamab, for Treatment of Newly Diagnosed Light Chain Amyloidosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study is for people who have newly diagnosed with AL (light chain) amyloidosis and have not yet received any treatment for this condition. The purpose of this study is to evaluate whether elranatamab, a type of immunotherapy drug, can produce deep remissions and organ recovery in people with newly diagnosed AL amyloidosis, and to compare two different dosing schedules. Elranatamab (brand name ELREXFIO™) is an investigational (experimental) drug in the setting of AL amyloidosis. It works by connecting immune cells (T-cells) directly to the abnormal plasma cells that are causing amyloidosis, triggering the immune system to destroy those cells. It is not approved by the Food and Drug Administration (FDA) for use in AL amyloidosis. Participants in this study will receive elranatamab as a series of injections under the skin (subcutaneously) over 6 treatment cycles (approximately 6 months). Treatment begins with inpatient "step-up" doses designed to reduce side effects, followed by either every-2-week or every-4-week dosing based on which study arm participants are randomly assigned to. Participants will have regular blood tests, physical exams, bone marrow biopsies, and heart assessments throughout the study, and follow-up visits for up to 2 years after treatment ends. This study is randomized, meaning that participants will be assigned by chance (similar to a coin flip) to one of two treatment arms. Participants cannot choose their arm. Participation in this research will last approximately 6 months of active treatment, followed by follow-up visits for up to 2 years (with an option to extend to 5 years).

Detailed description

Immunoglobulin light chain (AL) amyloidosis is a disorder of a certain type of blood cell (plasma cells). With this disorder, some plasma cells make abnormal, misfolded light chain proteins that can build up in tissues and organs, damaging them over time. In the United States, about 5 in every 100,000 people have this disorder. Even though it is rare, it can be very serious. Many people who have this disease are very sick upon diagnosis and require care from many different types of doctors. Cardiac (heart) involvement is the most common reason why people may get very sick and die. Contemporary plasma cell directed therapy has helped to improve outcomes, but many people still do not respond quickly or strongly enough. Some people still have worsening organ damage or cannot handle the strong treatments due to organ damage. In fact, early mortality is common, especially in people with cardiac involvement. There is a need for treatments that can quickly and safely lower harmful light chain levels, especially for people whose organs are already affected by the disease. Elranatamab is a type of drug called a bispecific antibody that connects a B cell maturation antigen (BCMA), a protein on plasma cells, with CD3, a protein on T cells. It can redirect T cells to kill plasma cells that are expressing BCMA. Treatments that use elranatamab have led to positive responses in people with multiple myeloma, a type of blood disease. There is early evidence to show that this drug may also help people with AL amyloidosis. This study will test elranatamab given for a set period of time in people with newly diagnosed AL amyloidosis. It will use two dosing schedules designed to balance efficacy with infection and tolerability risk in a population that is medically fragile.

Conditions

• Amyloid Light-chain Amyloidosis

Interventions

Type	Name	Description
DRUG	BCMA bispecific	All Participants will receive standard step-up dosing (SUD) of BCMA bispecific (elranatamab) in Cycle 1. They will receive 12 milligrams (mg) on Day 1, 32 mg on Day 3, 76 mg on Day 6, and one additional full dose (76 mg) on Day 13. They will then have 5 additional 28-day cycles, for a total duration of 6 months. For the 5 additional cycles, participants in Arm A will receive 76 mg of elranatamab every 2 weeks (q2). For the 5 additional cycles, participants in Arm B will receive 76 mg of elranatamab every 4 weeks (q4). The maximum duration of treatment for all participants is a total of 6 cycles (each 28 days in length), up to about 6 months.

Timeline

• Start date: 2026-06-01
• Primary completion: 2031-06-01
• Completion: 2031-06-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United States