The senior vice president and head of medical affairs at Orca Bio discussed the initiation of the Precision-T phase 3 trial.
“Orca Bio’s Precision-T study is a phase 3 randomized, multicenter study that's being conducted in the US. We are enrolling approximately 174 patients that are going to be randomized 1:1. One arm of patients will receive Orca-T and the other arm of patients will receive the standard of care allogeneic transplant.”
Orca Bio has initiated the phase 3 Precision-T clinical trial (NCT05316701) evaluating Orca-T, an allogeneic cell therapy, for the treatment of acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), and high-risk myelodysplastic syndromes (MDS).
Precision-T is comparing the safety and efficacy of Orca-T against standard of care allogeneic hematopoietic stem cell transplant (allo-HSCT). Orca-T has been developed with the intention of mitigating the risks of drawbacks to standard allo-HSCT including graft versus host disease (GVHD) and other transplant-related adverse events. The study will primarily be assessing the incidence of GVHD.
CGTLive spoke with Irene Agodoa, MD, senior vice president and head, medical affairs, Orca Bio, to learn more about the Precision-T study, which has begun dosing in centers around the US. She discussed the indications it is being assessed in as well as the origins of the therapy and the company.