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 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 |
TEMPORARILY_NOT_AVAILABLE | |
| NCT07216443 |
Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome |
RECRUITING | PHASE2 |
| NCT06551584 |
Phase I 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 |
