New FDA-Approved Treg Therapy to Reduce Chronic GVHD After Allogeneic HSCT

The Precision-T phase 3 trial is the first randomized, multicenter demonstration that a centrally manufactured defined allograft is effective markedly reducing moderate-to-severe chronic GVHD and non-relapse mortality without loss of graft versus leukemia or graft failure and infection. The engineered graft appears to instruct immune reconstitution toward a regulated, tolerance-associated state, giving the product a mechanism for further studies. The question is how far we can further program it.