CAR-T Meeting 2025 | ARI0003: a novel CD19/BCMA dual-targeting CAR T-cell therapy being investigated in a Phase I trial

To us, that we decided to make this ARI0001 and ARI0002 was quite easy because we used the two products to combine both. Most of the approaches made with CAR19 and CAR-BCMA from different companies to combine both of each complex, even the concept is very clear. You have good safety of the treatment, specifically in autoimmune diseases, but in general, for all the treatment with CAR-19 and CAR-BCMA, the adverse effect can be important, but in general, are manageable. And the safety in some way, it’s an important issue, but it can be managed. 

The combination of both can increase the efficacy of the concept because with CAR-19, you don’t kill plasma cells and with CAR-BCMA, you don’t kill the precursors of the B-cells that produce antibody. So our combination for us is a possibility to make a more deep effect in the pathway of the B-cells and the human response. And specifically to demonstrate efficacy as there is a clear need in a lot of different situations with non-Hodgkin lymphoma with B-cells, we decide to make the safety and the first studies of efficacies in this target because it’s clear that there are patients that lost the antigen, CD19, that it’s bad. The CAR has been approved for this non-Hodgkin lymphoma. [unintelligible] CD19, so if you lost the expression of the target in the tumor cells, you need to find an additional target, and BCMA, that it’s not mainly, it’s not approved for non-Hodgkin lymphoma, expresses BCMA, and we decide to combine both to increase the possibility of success of treatment of this avoiding the escape by losing one of the antigens and this is the situation why we are starting. 

We have been able to treat some patients right now and it’s clear that there are not important changes in the in the safety in relation to the use of the different CARs by separating and we are able to obtain dual CARs in an easy way and to test this to obtain safety and probably we expect an increase in efficacy of just CAR19, that is the comparative element, and maybe in the future we can move for this to other autoimmune diseases where it’s more important the role of antibodies and plasma cells at the same time and the CAR-T cells can be one and the other, both has been able to demonstrate CAR-19 and CAR-BCMA, some efficacy in autoimmune diseases but the combination of just some centers in China have been using this approach and we try to make this for maybe in the future. We have to be sure that in this non-Hodgkin lymphoma the safety is clear and there is some increase or some similar efficacy in the tumor cells, then later we can move to the autoimmune diseases or autoimmune patients.

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