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Orca-T is a cell therapy product that has demonstrated encouraging efficacy in patients with hematologic cancers in phase I/II studies. A phase III randomized trial that is comparing the product with standard-of-care hematopoietic stem cell transplantation is now underway.

In this 口袋女优 video, Caspian Oliai, MD, of the University of California Los Angeles, tells us about the initial phase Ib study.

Following is a transcript of his remarks:

The standard allograft in hematopoietic cell transplantation is a heterogeneous mixture of many types of cells. In comparison, Orca-T is separated into three specific components. Component number one are hematopoietic stem cells. Component number two are conventional T cells. And component number three are highly purified T regulatory cells.

Patients received infusions of the T regulatory cell component 2 days prior to the conventional T-cell component. That separation allows for the T regulatory cells to travel to the solid organs, create an immune barrier that protects potentially against graft-versus-host disease, so that by the time the conventional T cells arrive at the solid organs, there's less potential for graft-versus-host disease.

The trial design is a phase Ib multicenter trial with a primary objective of safety, but we're also looking at transplant outcomes as well, and some activity for efficacy. Patients received myeloablative conditioning therapy, the exact regimen is at the discretion of the treating physician. And then on day zero of the transplantation, patients received the hematopoietic stem cells followed by the infusion of the T regulatory cells. Subsequently on day +2, patients receive the infusion of conventional T cells. This is followed by tacrolimus single-agent graft-versus-host disease prophylaxis, running at a relatively low trough of five to 10.

This is a curative treatment modality, but the big unmet need is making the quality of life better for patients who go through this because it's a lot on the patient. It's a lot on their family. It's a lot of time invested. So there's a huge unmet need to improve the quality of life, and what we're showing is that graft-versus-host disease with Orca-T is low. And with that, that suggests that quality of life should be better when we have longer-term follow-up on the phase III trial. And this occurs potentially without compromising the curative potential of allogeneic transplantation.

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