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Open-Label Randomized Pilot Study to Assess the Safety, Tolerability and Antitumor Activity of Genetically Engineered NY-ESO-1 Specific (c259) T Cells Alone or in Combination with Pembrolizumab in HLA-A2+ Subjects with NY-ESO-1 and/or LAGE-1a Positive Relapsed and Refractory Multiple Myeloma
This study is intended for men and women at least 18 years of age who have relapsed and/or refractory multiple myeloma. This 2-arm randomized pilot study will test the safety, tolerability and efficacy of NY-ESO-1ᶜ²⁵⁹T alone (Arm 1) or in combination with pembrolizumab (Arm 2) in participants who have the appropriate HLA-A2 marker, and whose bone marrow expresses the NY-ESO-1 and/or LAGE-1a protein. This study will take a participant's T cells and give them a T cell receptor protein that recognizes and attacks the tumors.
Safety: To describe the safety and tolerability of autologous genetically modified T cells NY-ESO-1c259T) alone (Arm 1) or in combination with pembrolizumab (Arm 2) in subjects who are human leukocyte antigen HLA-A*02:01,HLA-A*02:05, and/or HLA-A*02:06 positive and have NY-ESO-1 and/or LAGE-1a positive relapsed refractory or primary refractory multiple myeloma. Efficacy: To describe the antitumor activity of autologous genetically modified T cells (NY-ESO-1c259T) alone (Arm 1) or in combination with pembrolizumab (Arm 2) in subjects who are HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 positive and have NY-ESO-1 and/or LAGE-1a positive relapsed refractory or primary refractory multiple myeloma. Exploratory: To evaluate minimal residual disease MRD) at 4 months post T-cell infusion(Week 15). To evaluate the persistence, phenotype,and functionality of NY-ESO-1c259 positive T cells. To understand mechanisms of resistance to NY-ESO-1c259T. To evaluate antigen spreading as a mechanism of response. To evaluate cytokine levels pre- and post-infusion on cytokine release syndrome (CRS). To evaluate the impact of germline polymorphisms in IL-6, TNF-alpha, IL-10, INF-gamma, and TGF-beta on CRS.
NY-ESO-1c259T (); Pembrolizumab (Keytruda); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)