The medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center discussed results from a phase 1b trial for allo-HCT alternative Orca-T that he presented at Tandem’s 2024 conference.
“Based on these promising phase 1B results, Orca-T has the potential to be a reduced-toxicity alternative to conventional allo-transplant.”
Allogeneic hematopoietic cell transplant (allo-HCT) is a standard of care treatment option for many patients with hematologic malignancies that can have a transformative or even curative effect on their disease. Although, it also carries a substantial risk of mortality through associated adverse events, especially Graft versus Host Disease (GvHD). This risk is especially high in older patients, and as such some of patients are ineligible for standard allo-HCT because the risk of mortality is too high. Allo-HCT also often requires the use of multiple immunosuppressants after transplant, which carry their own risks as well. Orca Bio has been attempting to address these issues with Orca-T, an investigational cell therapy product alternative to standard allo-HCT that consists of CD34+ stem cells, regulatory T-cells, and conventional T-cells from the peripheral blood of matched donors. Unlike in standard allo-HCT, the main component cell types of Orca-T are administered to patients in separate sequential steps, thus letting the regulatory T-cells to migrate to the solid organs first, allowing for the establishment of an immune barrier prior to the arrival of the conventional T-cells.
Orca-T has been evaluated in an ongoing phase 1b clinical trial (NCT04013685) in patients undergoing myeloablative allo-HCT for acute myeloid leukemia, acute lymphocytic leukemia, chronic myeloid leukemia, and myelodysplastic syndromes. The product is also now being evaluated in a phase 3 clinical trial (NCT05316701).
An analysis of results from the phase 1b trial comparing outcomes from younger patients (aged 18 to 54 years, median 47) and older patients (aged 55 years and older, median 59) was presented by Caspian Oliai, MD, MS, the medical director of the UCLA Bone Marrow Transplantation Stem Cell Processing Center, at the 2024 Tandem Meetings |Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR, held in San Antonio, Texas, February 21-24, 2024. Shortly after the close of the conference, CGTLive® interviewed Oliai to learn more about the outcomes of the analysis. Oliai emphasized some of the promising results seen so far, including a 0% transplant-related mortality rate at 1 year posttreatment for both the younger and older groups, and discussed future plans for Orca-T.
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