for Prevention of graft-versus-host disease in allogeneic HSCT for hematologic malignancies
Originally APR 6 2026; extended to JUL 6 2026 (Major amendment — updated CMC information submitted in response to FDA requests; not a safety or efficacy concern, announced APR 1 2026).
Allogeneic hematopoietic stem cell transplantation (HSCT) is a life-saving treatment for blood cancers but carries risks like graft-versus-host disease, where donor immune cells attack the patient's healthy tissues. Orca-T is a precision-engineered cell therapy that delivers a controlled mix of donor stem cells and regulatory T cells while removing harmful immune cells that trigger attacks. This approach may reduce graft-versus-host complications while maintaining the cancer-fighting benefits of the transplant.