Stanford launches first commercial use of Orca-T blood cancer transplant after FDA nod

After more than two decades of development, Stanford’s Orca-T transplant therapy received FDA approval in June 2026, based on a phase-3 trial where 78% of patients were free from moderate-to-severe graft-versus-host disease (GVHD) one year after transplant, versus 38.4% with conventional methods. The therapy, now marketed as Tregzi, uniquely separates donor cell populations and delivers them in a staged sequence—stem cells, regulatory T cells, then mature immune cells—to balance cancer-fighting activity with reduced immune attack on the patient’s tissues.

Stanford Medicine has now treated its first commercial patient, a high-risk leukemia case, outside a trial setting, offering a lower-chemotherapy option with fewer side effects. Robert Negrin, a longtime Stanford Cancer Institute researcher, was instrumental in the therapy’s development. Researchers continue to test Orca-T in older adults, alongside CAR-T therapies, and for patients without matched donors, aiming to broaden its applicability.