Samer A. Srour, MD, MS, discusses what challenges need to be faced when moving forward with the phase 1 trial of Orca-Q in patients undergoing haploidentical allogeneic hematopoietic stem cell transplantation.
Samer A. Srour, MD, MS, The University of Texas MD Anderson Cancer Center, Houston, Texas, discusses what kind of challenges need to be faced when moving forward with the phase 1 trial (NCT03802695) of Orca-Q in patients undergoing haploidentical allogeneic hematopoietic stem cell transplantation (HSCT).
Currently, Orca-Q, a next-generation investigational cell therapy, is being evaluated in a 3-arm, phase 1 study (NCT03802695) of patients undergoing HSCT for hematologic malignancies. Initial data on Orca-Q have shown there to be good clinical outcomes with the agent, including a reduction in rates of acute and chronic graft-vs-host disease (GVHD) and improved GVHD relapse-free survival among patients.
Researchers aim to further validate these findings, and the trial continues to enroll patients across the United States.
0:10 | The study is still accruing. Since those 26 patients were treated, we have added more patients to this cohort, and we definitely need to add more patients and we need a little bit more time, maybe like 6 more months to make sure that these results are validated with higher sample size and longer follow-up, which I hope it will. The next step should be automatically to go to a randomized clinical trial where we say we have this new, novel, first-in-human Orca-Q.
0:43 | For me, the Q stands for quality-of-life. This is a good platform, not just to improve the outcomes of these applications, but also to improve their quality-of-life with less toxicity. We have to randomize patients to this compared with the conventional way of doing transplant, which is most commonly done with cyclophosphamide given after transplant. That will be my goal, to work with my colleagues and co-authors on this study to proceed with that randomized study as soon as possible so we can get the best answer in the coming couple of years or so and determine whether this should be a new standard of care for our patients.