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Enrollment has begun on a phase 3 clinical trial assessing the safety and efficacy of an investigational cell therapy in patients with acute myeloid leukemia, acute lymphocytic leukemia and myelodysplastic syndromes.
Patients with acute myeloid leukemia, acute lymphocytic leukemia and myelodysplastic syndromes — types of a rare blood cancers — have begun receiving treatment with an investigational cell therapy across multiple cancer centers as part of a phase 3 clinical trial.
The study, known as Precision-T, is being conducted to assess the safety and efficacy differences between standard of care allogeneic hematopoietic stem cell transplant and Orca-T, a novel cell therapy.
Of note, an allogeneic hematopoietic stem cell transplant is a procedure in which a patient receives healthy stem cells from a related or unrelated donor to replace their damaged stem cells that have been affected by radiation or high doses of chemotherapy.
Orca-T is classified by its manufacturer, Orca Bio, as a high-precision cell therapy that combines purified cells from a matched donor. The investigational cell therapy is designed to not only replace a patient’s diseased blood and immune system with healthy cells, but also to reduce the risk for developing life-threatening transplant-related side effects such as graft versus host disease.
In graft versus host disease, the bone marrow or stem cells that have been transplanted into the patient with cancer views the recipient’s body as foreign. As a result of this, the donated cells or bone marrow begin to attack the recipient.
“By precision engineering the donor graft, we aim to create a cell therapy that retains the benefits of transplant without serious complications like graft versus host disease and disease relapse,” Dr. Robert Negrin, professor of medicine at the Stanford School of Medicine in California, said in a press release. “This has been demonstrated by the recent results of the phase 1b/2 single-arm trials with Orca-T, and we are pleased to be evaluating this novel cell therapy in a randomized phase 3 clinical trial.”
Orca Bio noted that it is expected that approximately 174 patients across more than 20 cancer centers — including City of Hope in California as well as the Winship Cancer Institute of Emory University in Atlanta.
The main goal of the phase 3 trial is to identify the rate of moderate-to-severe chronic graft versus host disease-free survival among patients who receive Orca-T compared with those who receive standard of care allogeneic hematopoietic stem cell transplant. The investigators have defined moderate-to-severe chronic graft versus host disease-free survival as being death by any cause of moderate-to-severe chronic versus graft host disease.
Additionally, the study authors aim to assess each treatment’s effect on relapse-free survival (survival free of death from disease relapse) as well as graft vs. host disease and relapse-free survival, which is being defined as survival free of death from any cause, relapse, serious or severe acute graft versus host disease and moderate to severe chronic graft versus host disease.
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