Actively Recruiting
Phase 1b2 Study of AZD0120, a CAR T Cell Therapy Targeting CD19 and BCMA, in Adults With Relapsed or Refractory AL Amyloidosis
Led by Alexion Pharmaceuticals, Inc. · Updated on 2026-07-02
91
Participants Needed
18
Research Sites
78 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0120, a CAR T cell therapy targeting CD19 and B Cell Maturation Antigen BCMA, in participants with relapsed or refractory light chain AL amyloidosis. This open-label Phase 1b2 study aims to assess the safety, tolerability, and efficacy of AZD0120 in this patient group. Participants must have a confirmed diagnosis of AL amyloidosis affecting one or more organs and measurable hematologic disease. Participants will receive a weight-based dose of AZD0120 administered by intravenous infusion. The study includes a single treatment group where all participants receive the investigational drug. The trial is designed to monitor the impact of AZD0120 on participants with relapsed or refractory AL amyloidosis following at least one prior anti-plasma cell therapy. During the study, participants will undergo assessments to monitor treatment-emergent adverse events and hematologic response, including complete response rates. Blood levels of AZD0120 will also be measured over time. Follow-up will continue for a minimum of six months to evaluate safety and efficacy outcomes. Participants are expected to attend scheduled study visits and comply with protocol requirements throughout the trial duration.
CONDITIONS
Brief Title
A Phase 1b/2 Study of CAR T Cell Therapy Targeting CD19 and BCMA in Participants With Relapsed or Refractory AL Amyloidosis.
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
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