ClinicaliQ Trial Snapshot
- A Trial to Learn if Linvoseltamab is Safe and Works in Adults With Relapsed or Refractory Systemic Light Chain Amyloidosis (AL Amyloidosis) — Recruiting • Phase I • Cardiology / Cardiovascular • NCT06292780.
- Treatment being tested: Linvoseltamab, an experimental monoclonal antibody targeting serum amyloid A, is being evaluated for safety and efficacy in adults with relapsed or refractory AL (light chain) amyloidosis who have failed prior therapeutic interventions.
- Patient eligibility overview: The trial enrolls adult patients with systemic AL amyloidosis that has either recurred after initial treatment response or demonstrated primary refractoriness to previous therapy, requiring alternative treatment options.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
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…
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.