BRL-302 Phase 1: A New CAR-T Cells Therapy for mCRPC

A new clinical trial has begun, offering a new approach to treating advanced prostate cancer that has become resistant to standard therapies. This Phase 1 study (NCT06895811), is investigating a cutting-edge cellular therapy called PSMA-Universal Chimeric Antigen Receptor (UCAR) T-lymphocytes, or BRL-302, with a strong focus on patient safety and control.

Unlike traditional CAR T-cell therapies, which are “always on” once infused, this new UCAR technology is designed to be “switchable”. Imagine a light switch: the T-cells are engineered to recognize a universal signal, and a separate “targeting module” acts as the light switch, directing these T-cells specifically to prostate cancer cells. The key advantage? If side effects become too strong, doctors can simply stop giving the targeting module, effectively turning off the T-cells’ activity within hours. This rapid control mechanism is a significant step forward, aiming to reduce the severe side effects, like high fevers and confusion, that have sometimes been seen with earlier CAR T-cell treatments for solid tumors.

The trial is currently recruiting a small initial group of three patients. This cautious approach is deliberate: researchers will carefully evaluate the safety and initial effects of the first dose level. Unusually for a Phase 1 study, the trial design even allows for the dose to be decreased if needed, highlighting the priority placed on patient well-being given the complexities of these advanced therapies.

Clinical trial.