Testing linvoseltamab for treating relapsed or refractory AL amyloidosis in adults
A Phase 1/2 Study of Linvoseltamab in Patients With Relapsed or Refractory Systemic Light Chain Amyloidosis
This study is testing a new drug called linvoseltamab to see if it can help adults with relapsed or refractory AL amyloidosis feel better and improve their organ function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | linvoseltamab |
| Locations | 19 sites (Duarte, California and 18 other locations) |
| Trial ID | NCT06292780 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of an experimental drug called linvoseltamab in adults suffering from relapsed or refractory systemic light chain amyloidosis (AL amyloidosis). The study is divided into two phases: Phase 1 focuses on determining the recommended doses and assessing side effects in a small group of participants, while Phase 2 expands the participant pool to further evaluate the drug's effectiveness and safety. The trial also aims to measure improvements in abnormal proteins and organ function, particularly in the heart and kidneys, among those treated with linvoseltamab.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed diagnosis of AL amyloidosis who have previously undergone treatment and require further therapy.
Not a fit: Patients with other forms of amyloidosis or significant cardiac issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed or refractory AL amyloidosis.
How similar studies have performed: Other studies have explored treatments for AL amyloidosis, but the specific approach with linvoseltamab is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1. Confirmed diagnosis of AL amyloidosis, as described in the protocol 2. Measurable disease as defined by serum difference between involved and uninvolved free light chains (dFLC) concentration, as described in the protocol 3. Previously treated after at least 1 prior therapy and requiring further treatment as assessed by the Investigator 4. N-terminal pro b-type natriuretic peptide (NT-proBNP) ≤8500 ng/L during screening 5. Adequate hepatic, hematologic, renal, and cardiac function, as described in the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance score ≤2 at screening Key Exclusion Criteria: 1. History of other non-AL amyloidosis 2. Greater than 60% plasmacytosis on a bone marrow biopsy and/or aspirate during screening 3. Presence of lytic bone lesion(s) or extramedullary plasmacytoma on imaging during screening 4. Myocardial infarction within the past 6 months prior to the first screening visit 5. Known active infection requiring hospitalization or treatment with IV anti-infectives within 28 days of first administration of study drug NOTE: Other protocol defined inclusion/exclusion criteria apply
Where this trial is running
Duarte, California and 18 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- Colorado Blood Cancer Institute/SCRI — Denver, Colorado, United States (Recruiting)
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
- Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States (Recruiting)
- Ohio State University — Columbus, Ohio, United States (Recruiting)
- SCRI Oncology Partners — Nashville, Tennessee, United States (Recruiting)
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
- National and Kapodistrian University of Athens — Athens, Greece (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Asan Medical Center — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul St. Mary's Hospital - The Catholic University of Korea — Seoul, South Korea (Recruiting)
- Hospital Universitari Son Espases — Palma, Balearic Islands, Spain (Recruiting)
- Clinica Universidad de Navarra - Pamplona — Pamplona, Navarre, Spain (Recruiting)
- Hospital de Cabuenes — Gijón, Principality of Asturias, Spain (Recruiting)
- Universität de Barcelona- Institut d' Investigacions Biomediques August Pi i Sunyer (IDIBAPS) — Barcelona, Spain (Recruiting)
- University Hospital La Fe — Valencia, Spain (Recruiting)
- University College London Hospitals — London, United Kingdom (Recruiting)
- The Christie NHS Foundation Trust — Manchester, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.