Anvisa Authorizes new CAR-T cells clinical trial in Brazil.
The National Health Surveillance Agency (Anvisa) approved the performance of the first clinical trial for the development of a national gene therapy product based on CAR-T cells for the treatment of cancer.
The clinical research will be carried out by Hospital Israelita Albert Einstein, with funding from the Unified Health System (SUS).
Under development in several countries around the world, the technology that uses CAR-T cells is considered very promising and consists of genetically reprogramming the cells of the patient’s defense system to recognize and fight the tumor that affects them.
This type of treatment has been used in patients with B-cell lymphomas, in case of recurrence of tumors or resistance to standard treatment.
At this first moment, few patients should participate in the study. The clinical trial is in the initial phase of development and should be controlled to assess the risks and benefits of the drug.