A Phase 1B/3 Study of Orca-T in People With Blood Cancers


Full Title

A Phase Ib /Randomized Phase III Trial of Patients with Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation with Either Orca-T, a T-cell-Depleted Graft with Additional Infusion of Conventional T cells and Regulatory T cells, or Standard-of-Care Allogeneic Graft


In this study, researchers are assessing a new treatment for blood cancers called Orca-T. In the first part (phase 1B), they will look at the safety of Orca-T. In the second part (phase 3), they will compare Orca-T with a conventional stem cell transplant.

Orca-T is called a “cellular therapy.” It is made in a lab starting with white blood cells (called T cells) and healthy, blood-forming cells (stem cells). These cells are collected from a healthy donor. Orca-T is given during a transplant procedure. It may help your body fight cancer. It may also lower the risk of problems like graft-versus-host disease (GVHD). GVHD happens when donated cells see healthy tissues in your body as foreign and attack them. It is hoped that Orca-T works well for treating blood cancers without the risk of GVHD.

Who Can Join

To join this study, there are a few conditions. You must:

  • Have a blood cancer that needs to be treated with a stem cell transplant. Examples include acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), myelofibrosis, and myelodysplastic syndrome (MDS).
  • Have a matched related or unrelated stem cell donor.
  • Be age 18-75 (for the phase 1B part of the study) or 18-65 (for the phase 3 part).


For more information and to see if you can join this study, please contact Dr. Roni Tamari at 646-608-3738.




Phase I (phase 1)



ClinicalTrials.gov ID