Following the FDA approval of allogeneic regulatory T cell–containing immunotherapy with hematopoietic stem and progenitor cell (HSPC) and T cells-vldq (Tregzi; Orca-T), CancerNetwork® spoke with Wendy Stock, MD, about what this decision means for the treatment of patients undergoing hematopoietic stem cell transplantation for different hematologic malignancies. Additionally, she discussed how this option fits into the treatment landscape alongside other options like posttransplant cyclophosphamide (PTCy) and other next steps for improving outcomes associated with matched donor transplants.

Stock reviewed findings from the phase 3 Precision-T trial (NCT05316701) that supported the approval of Orca-T, noting that the data appeared to be “effective across all populations” for patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome (MDS), and mixed-phenotype acute leukemia. Furthermore, she detailed what adoption of Orca-T might look like on an operational level, described the agent’s ability to reduce the risk of graft-versus-host disease, and emphasized referring patients early to transplantation.

The approval, Stock said, marks the beginning of potentially allowing “higher-risk populations to move forward with the knowledge that it is possible to undergo transplant safely.” She noted that the FDA’s decision may inspire the field of transplant graft engineering to look more carefully at other options that might further improve transplantation outcomes.

“Over the last 10 years, we have had incredibly exciting, still-to-be-tweaked methods for improving outcomes for patients undergoing transplant, which is such an important procedure for curing or [achieving] long-term survival for patients with acute leukemias and high-risk myelodysplastic syndromes,” Stock said. “This is a big advance, and it needs to be studied further, including comparisons with other major improvements in the world of transplant, such as PTCy.”

Stock is the Anjuli Seth Nayak Professor of Medicine, cochair of the Leukemia Committee for the National Cancer Institute–supported Alliance for Clinical Trials in Oncology, and coleader of the Clinical and Experimental Therapeutics Research Program at the University of Chicago Medicine Comprehensive Cancer Center.

References

FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies. News release. FDA. June 30, 2026. Accessed July 15, 2026. https://tinyurl.com/38s3wznr
Meyer EH, Salhotra A, Gandhi AP, et al. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026;147(11):1168-1177. doi:10.1182/blood.2025031313