Up-front CART-BCMA With or Without huCART19 in High-risk Multiple Myeloma

Summary

This is an open-label, phase 1 study to assess the safety, pharmacodynamics, and anti-myeloma effects of autologous T cells expressing BCMA (B-cell maturation antigen)-specific chimeric antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains (referred to as "CART-BCMA"), with or without huCART19 (also known as CTL119), in patients responding to first- or second-line therapy for high-risk multiple myeloma, and in relapsed/refractory multiple myeloma patients responding to salvage therapy.

Timeline

Start

2018-05-09

Primary completion

2036-03

Completion

2036-03

Publications

• Zhang Z, Markmann C, Yu M, Agarwal D, Rostami S, Wang W, Liu C, Zhao H, Ochoa T, Parvathaneni K, Xu X, Li E, Gonzalez V, Khadka R, Hoffmann J, Knox JJ, Scholler J, Marcellus B, Allman D, Fraietta JA, Samelson-Jones B, Milone MC, Monos D, Garfall AL, Naji A, Bhoj VG. Immunotherapy targeting B cells and long-lived plasma cells effectively eliminates pre-existing donor-specific allo-antibodies. Cell Rep Med. 2023 Dec 19;4(12):101336. doi: 10.1016/j.xcrm.2023.101336.

Drugs

Indications