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The other effect of the allogeneic CAR T cells is that the re-stimulation of the T cells will also be universal, even when the patient is receiving autologous CAR T cells. One of the challenges for administration of autologous CAR T cells is the potential for the disease to mutate over time, and current therapies cannot be perfectly effective against all of the variants. Along this same line, the allogeneic CAR T cells are not subject to the same degree of selection pressure and will thus be able to be effective against some of the variations and can potentially provide improved efficacy against others. Indeed, several case reports have shown that patients with various genetically altered myeloma have benefited from the infusions of allogeneic CAR T cells101-103. These earlier studies demonstrated the safety of allogeneic CAR T cells, and the encouraging results encouraged us to embark on their large-scale clinical investigation as a potential therapeutic option. As a proof-of-principle, we utilized ex vivo expanded CD19-specific CAR T cells to treat 2 heavily pretreated patients with relapsed/refractory CD19-positive myeloma. These patients have been heavily treated with multiple lines of high-dose chemotherapy and autologous CAR T cells have shown only limited clinical activity. We demonstrated the safety of co-infusion of the allogeneic cells, both in terms of cytokine release syndrome (CRS) and GVHD105. The most important finding from these studies is that the allogeneic CAR T cells were able to expand the CD19-specific T cells, and this expansion was likely due to recognition of the allogeneic CAR T cells. Furthermore, these expanded CD19-specific T cells were able to persist in the blood and tissues of the patients and exhibit a modest lymphodepletion in the bone marrow105. There are several limitations to this small proof-of-concept study. The expansion of the T cells was transient and is likely due to the strong recognition of allogeneic CAR T cells. Long-term persistence of these allogeneic CAR T cells would require the engineering of these cells with indel-resistant CARs. Furthermore, the use of allogeneic CAR T cells is associated with several challenges, such as ensuring consistent manufacturing, ensuring sufficient supplies for treatment of relapsed/refractory disease, and establishing a suitable manufacturing process.
Despite the challenges in HSCT, the cost is the most significant factor for feasibility of this modality in clinical practice. As mentioned, the current cost of autologous T-cell manufacturing are prohibitive in many MM patients. In addition, the maintenance of the autologous T cells is expensive, time consuming, and cumbersome. Thus, the cost of the HSCT would also be prohibitive.
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