We have an academic development of CAR-T cells in our institution and we have already CAR-T for CD19 malignancies, ARI0002, ARI0001, that are used as hospital treatment in Spain. Following this development we also have some preclinical studies about in vivo and in vitro efficacy of a CAR against BCMA. That is our ARI0002H.
What was the methodology behind this study?
We decided to give this trial to patients with at least two lines of treatment for multiple myeloma that were refractory to their last line of treatment and expose them to the main family of drugs. The idea was to give two doses of three million CAR-T cells, one initially, one dose, and a second dose four months later, at least four months later, for patients with some degree of response and no relevant toxicity. The idea coming from our CD19 experience was also fractionating the first dose into three infusions.
What were the key findings?
We are very lucky that all the patients showed at least partial response. In fact, 63% are in complete remission and 93% in very good partial response or better. The toxicity in general is mild in terms of cytokine release syndrome – 90% of the patients have cytokine release syndrome but it’s always grade 1 or 2. We have no cases of acute neurotoxicity or late neurotoxicity.
What impacts could these results have and what is next for the study?
We are now recruiting a second cohort of another 30 patients, because the first study was performed in 30 patients, in order to confirm the results in efficacy and safety. But we would like to have the possibility to offer our treatment to patients in Spain and, why not, even in other countries in Europe, because we know there is a lack of standard treatment for patients when they have refractoriness, for example to lenalidomide, to daratumumab, the options are more limited. We think that our CAR, ARI0002H, is a promising therapy for these patients.
Anything else to add?
I think that it’s very important that we encourage researchers in Europe and in other countries for developing this kind of academic strategy now that we are facing this new era for the treatment of patients in myeloma and other haematological malignancies with immunotherapy such as CAR-T cells. It is very important to reinforce the possibility to academic development.