A Phase I/Phase II Clinical Trial is ongoing to test the Italian version Car-T therapy, called Carcik, aimed at treating LLA – Acute Lymphoblastic Leukemia – at the San Gerardo Hospital in Monza and at the Papa Giovanni XIII Hospital in Bergamo.

Compared to the first Car-T therapies, there could be many advantages for patients suffering again from LLA, after a failed hematopoietic stem cell transplant. First of all, in this case, apheresis is not necessary; only 50 mL donor cells are needed, which do not necessarily need to derive from a relative.

In the second instance, Car transduction is based upon the electroporation technique and not upon the common viral vector, making it easier and more economical. Last but not least, no cases of toxicity have been reported, in particular neurotoxicity or cytokine storm, the worst Car-T therapy complications. This may also be possible for the different types of T lymphocytes employed, which also have Natural Killer markers.

Moreover, there is evidence that these cells are able to persist and be active in the long-term: as in Car-T, this therapy leads to remission after the 28^th day, following the administration of Carcik.

At this very moment, the clinical protocol is still open to recruiting both pediatric and adult patients: this is noteworthy, considering that until now Car-T therapy was only for LLA patients under 25 years old.