Myeloma Clinical Trial
Official title:
Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM. To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
Primary Objectives: - Part A: To assess dose-limiting toxicity (DLT) and determine the safety and optimal cell dose of NY-ESO-1 TCR/IL-15 NK cells in patients with relapsed/refractory multiple myeloma. - Part B: To assess the day +90 overall response rate in patients treated at the optimal cell dose. Secondary Objectives: - Assess day +180 progression-free survival (PFS). - Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient. - To conduct comprehensive immune reconstitution studies. - To obtain preliminary data on quality of life and patient experience. - Assess duration of response (DOR) Secondary end points - Day +180 PFS rate; - NY-ESO-1 TCR/IL-15 NK cell numbers in peripheral blood vs time profile; - Characterization of lymphocyte populations at various time points; - PROMIS-29 quality of life questionnaire score. - Duration of response ;
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