A Modular, Phase I, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Immunogenicity, Pharmacodynamics, and Preliminary Efficacy of AZD0120, a Dual-targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19 in Participants With Multiple Myeloma (DURGA-2)
AstraZeneca
Summary
This is an interventional, modular, open-label, multicenter study to primarily evaluate the safety and tolerability of AZD0120 in adult participants with multiple myeloma (MM).
Description
This modular study aims to evaluate the safety, tolerability, cellular kinetics, pharmacodynamic effect, immunogenicity, and preliminary efficacy of AZD0120 in subjects with newly diagnosed or early relapsed or primary refractory multiple myeloma. Module 1 consists of early line MM (including newly diagnosed MM and early relapsed or primary refractory MM) with AZD0120 (for newly diagnosed multiple myeloma (NDMM), the intervention is with AZD0120 ± maintenance). Module 2 consists of NDMM with AZD0120 ± maintenance.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Age: * Males and females ≥18 years of age at the time of consent Type of Participant and Disease Characteristics: * Participant must have documented diagnosis of MM per IMWG diagnostic criteria * ECOG performance status of 0 or 1. * Adequate organ and bone marrow function. For NDMM participants: * Participants on Module 1: Newly diagnosed multiple myeloma (NDMM) without prior anti- myeloma therapy (no more than 2 cycles of induction therapy before enrollment are acceptable) * For participants on Module 2: Newly diagnosed MM with a minimum of 4 cycles and a maximum of…
Interventions
- BiologicalAZD0120
AZD0120 is a BCMA/CD19 dual CAR T cell product under investigation for early-line treatment in subjects with multiple myeloma
Locations (13)
- Research SitePhoenix, Arizona
- Research SiteDuarte, California
- Research SiteDenver, Colorado
- Research SiteTampa, Florida
- Research SiteAtlanta, Georgia
- Research SiteIowa City, Iowa