Orca-T is an investigational allogeneic stem cell and T-cell immunotherapy biologic for hematologic malignancies and transplant settings. It consists of purified hematopoietic stem/progenitor cells, regulatory T cells, and conventional T cells from matched donors. The program has advanced through phase 2/3 studies and is under FDA Priority Review via BLA, but remains unapproved.
The FDA approved Tregzi (Orca-T), a first-of-its-kind regulatory T cell-based immunotherapy, for adults with blood cancers undergoing matched donor stem cell transplants. Approval was based on the PRECISION-T trial, in which 78% of treated patients achieved chronic GVHD-free survival at one year versus 38.4% with standard transplant.
The FDA has approved Tregzi, a donor-derived T-cell immunotherapy, to reduce the risk of chronic graft-versus-host disease following stem cell transplant in adults with high-risk blood cancers. In a pivotal trial, 78% of recipients were alive and free of severe chronic GVHD at one year versus 38.4% with standard transplant.
The FDA approved Orca-T (Tregzi) for matched donor hematopoietic stem cell transplantation in adults with hematologic malignancies. Phase 3 Precision-T data showed reduced graft-versus-host disease across leukemia and MDS populations, with experts calling it a 'big advance' requiring further comparison with post-transplant cyclophosphamide.
The 2026 Tandem Meetings featured new data on CAR-T, allogeneic transplantation, and supportive care. Highlights included early efficacy signals for EB-103, KITE-753, Orca-T, and NXC-201, plus comparative cardiovascular safety data for lisocabtagene maraleucel.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Orca-T, an investigational T-cell therapy under FDA priority review, is being studied to reduce graft-versus-host disease in patients undergoing allogeneic stem cell transplant for acute leukemias and high-risk blood disorders, with a decision expected in April 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07346105 |
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies |
AVAILABLE | |
| NCT07216443 |
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome |
RECRUITING | PHASE2 |
| NCT06551584 |
Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT |
RECRUITING | PHASE1 |
| NCT05316701 |
Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT04013685 |
Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies |
ACTIVE_NOT_RECRUITING | PHASE1 |
