Evaluating Safety and Effectiveness of LVIVO-TaVec200 in Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating the LVIVO-TaVec200 product in a dose-escalation and dose-expansion clinical study for adults with relapsed or refractory multiple myeloma who have not responded to at least three prior standard treatments. This early phase 1 study aims to assess the safety, tolerability, anti-tumor effects, and how the product behaves in the body over time. The study is open-label and single-arm, focusing on this specific patient group with measurable disease and a reasonable life expectancy. Participants will receive a single infusion of the LVIVO-TaVec200 product at increasing dose levels. Before the infusion, some participants may receive bridging therapy if needed. The study includes a core period lasting about two years, which covers screening, bridging therapy, treatment, and follow-up phases. Researchers will monitor patients closely throughout this time to determine the recommended dose for future studies. During the study, participants will undergo various assessments, including monitoring for treatment-emergent adverse events, and testing the pharmacokinetics of the product in peripheral blood and bone marrow. These evaluations will continue through the two-year follow-up period after infusion. Participants will be regularly assessed for safety and treatment effects, with ongoing follow-up to track their response and health status throughout the study duration.

A Clinical Study to Evaluate LVIVO-TaVec200 for the Treatment of Relapsed/Refractory Multiple Myeloma