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An Open-Label Phase I, Multi-Center Study to Determine the Recommended Dose of the Chimeric Antigen Receptor T-cell Treatment CYAD-211 After a Non-Myeloablative Preconditioning Chemotherapy in Multiple Myeloma Patients with Relapsed or Refractory Disease (IMMUNICY-1)
This study aims to determine the recommended dose of the allogeneic CYAD-211 (anti-BCMA CAR-T) cells after a non-myeloablative preconditioning chemotherapy in multiple myeloma (MM) patients with relapsed or refractory disease.
Primary Objective: The primary objective of this Phase I study is to determine the recommended dose (RecD) for the CYAD-211 investigational product when administered as a single infusion after a non-myeloablative preconditioning chemotherapy in MM patients with relapsed or refractory disease. Secondary Objectives: The secondary objectives of this Phase I study are: -Evaluation of additional safety parameters -Evaluation of indicators of clinical activity Exploratory Objectives: Exploratory objectives of this Phase I study are: -Kinetics of CYAD-211 in peripheral blood, bone marrow and extramedullary tumor sites/plasmacytoma -Systemic cytokine and chemokine kinetics -BCMA and other immune targets expression on normal cells and tumor cells in bone marrow, extramedullary tumor sites/plasmacytoma, and peripheral blood -soluble BCMA and other immune targets kinetics -evolution of the clonality of tumor cells in bone marrow samples or aspirate -Degree of HLA mismatching between each patient treated and CYAD-211 -Phenotype of CYAD-211 T-cells post-infusion and relative frequency of T-cell subsets -Patient's immune response against CYAD-211
CYAD-211 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)