FDA Approves First T Cell Progenitor to Enter Human Trials

The FDA has approved Smart Immune’s investigational new drug (IND) application for ProTcell, a T cell progenitor-based biotherapy candidate, marking the first time the agency has cleared a product of its kind to enter clinical trials.

Paris, France-based Smart Immune said ProTcell will enter a U.S. phase 1/2 trial by fall, where it will be evaluated as a treatment for acute lymphocytic leukemia and acute myelocytic leukemia.

The trial will enroll up to 36 participants and evaluate ProTcell’s ability to rapidly generate T cells in patients to reduce infections, Graft-versus-host disease and one-year non-relapse mortality.