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NCT07524634 · ClinicalTrials.gov registry record · Phase 2
Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Not yet
- Registry status
- Phase 2
- Development phase
- 64
- Enrollment target
NCT07524634 is a Phase 2 study that has not yet begun recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 64 participants.
The verdict
NCT07524634, a Phase 2 study, has not yet begun recruiting, sponsored by Case Comprehensive Cancer Center.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 64 participants
- Enrollment target
Study 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 two different dosing schedules 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).
Interventions
- DRUG BCMA bispecific
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2026-06 |
| Est. Completion | 2031-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07524634
The ClinicalTrials.gov registry entry for NCT07524634 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 64 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BCMA bispecific is the first listed.
NCT07524634 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07524634 about?
NCT07524634 is a clinical study titled "Dose Schedule Study of BCMA Bispecific Antibody, Elranatamab, for Newly Diagnosed Immunoglobulin Light Chain (AL) Amyloidosis". 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 peopl...
What is the current status of trial NCT07524634?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 64 participants. The study started on 2026-06. Estimated completion is 2031-06.
What interventions are being tested in trial NCT07524634?
The interventions under investigation include: BCMA bispecific (DRUG).
Who is sponsoring clinical trial NCT07524634?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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