Brazilian CAR‑T Therapy Shows 87.5% Response in Early Trial

Overview

• The Ministry of Health presented preliminary phase I/II results on Wednesday showing a 87.5% response rate in treated non‑Hodgkin lymphoma patients, with data described as early and not yet peer reviewed.
• The trial is led by USP’s Hemocentro de Ribeirão Preto with Instituto Butantan and has enrolled 75 participants so far, 25 of whom have received CAR‑T infusions as the study continues to recruit toward its target of at least 100 patients.
• A federally funded R$100 million program includes a Ribeirão Preto manufacturing facility said to have capacity for roughly 1,000 therapies, which officials say could cut costs compared with private treatments that can run into millions of reais.
• ANVISA’s Innovas committee will monitor the study and regulators say safety and efficacy analyses require at least one year of follow‑up per patient, with authorities estimating about 12–18 months to complete analyses and consider registration.
• Patients treated compassionately report durable remissions and researchers plan to expand CAR‑T testing to autoimmune diseases and to train a network of SUS hospitals to deliver the therapy if it wins regulatory approval.