A Single Center, Non-Randomized, Phase 1b Study of Orca-T Following Escalated Dose of Total Marrow and Lymphoid Irradiation in Patients With Acute Leukemias and MDS

What's the purpose of the trial?

This phase I trial tests the side effects and best dose of total marrow lymphoid irradiation along with chemotherapy, with fludarabine and melphalan, with or without thiotepa, in combination with Orca-T cells for patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS). Total marrow and lymphoid irradiation is a targeted form of total body irradiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Giving chemotherapy with medications such as thiotepa, fludarabine, and melphalan before a treatment with stem cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Orca-T cells take cells from a donor and remove some of the T cells and replace them with partially engineered T cells in order to induce better tolerance in patients. Giving total marrow and lymphoid irradiation and chemotherapy followed by Orca -T cells may be an effective treatment for patients with AML, ALL or MDS.
Trial status

Accepting patients

Phase 1
Last Updated
5 months ago
Am I Eligible

Participating Centers

There is one center participating in this trial. Enter a location below to view the distance.

Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Fludarabine is a chemotherapy medication that may be used in the treatment of many different cancers.
  • Melphalan is a chemotherapy medication used in the treatment of different cancers.
  • Orca-T is a T cell therapy made from stem and T cells. Orca-T is made from allogeneic donors, and is specialized to try and minimize allogeneic transplant side effects. 
  • Tacrolimus is an immunosuppressive medication used to help prevent rejection in patients who have had a transplant.
  • Thiotepa is an antineoplastic chemotherapy agent that is used to treat several different kinds of cancer.

Arms / Cohorts

Explore eligibility, treatments and learn more about potential cohorts.

Accepting patients

TMLI + Fludarabine + Melphalan + Orca-T

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