So we all know that PTCy changed the field in GVHD prevention for, you know, helping break the HLA barrier and making more donors available for our patients. However, post-transplant Cy, still there’s a lot more work to do regarding, you know, what’s the best dose, what’s the best combination, because still some patients cannot tolerate the dose and timing that we do right now...
So we all know that PTCy changed the field in GVHD prevention for, you know, helping break the HLA barrier and making more donors available for our patients. However, post-transplant Cy, still there’s a lot more work to do regarding, you know, what’s the best dose, what’s the best combination, because still some patients cannot tolerate the dose and timing that we do right now. Some patients can develop cardiac toxicity, hemorrhagic cystitis, and some even develop a TMA, thrombomicro angiopathy. A lot of studies are trying to see what is the best combination, better dosing. One of the things we are investigating is combination with human chorionic gonadotropin.
This is a phase one dose escalation study, so still in the early stages of this study. But the background behind it is human chorionic gonadotropin, it was shown to help in increase in Tregs, especially like, you know, people in pregnancy, you know, those, some of these autoimmune diseases go away it helps with the, you know, with the pregnancy, but also some of the medications with human chorionic gonadotropin, they have epidermal growth factor that also might help with the healing of the intestine after chemotherapy.
So this is very early, only four patients, dose escalation, phase one dose escalation study. We chose the scheduling of the human chorionic gonadotropin at day seven, nine, and 11, with the doses of 250, 500, and 1,000 international units. So far, we have four patients dosed without any dose-limiting toxicity. All patients engrafted, no graft failure, 100% donor chimerism. Now, acute GVHD only developed in one patient, only at grade two. None developed grade three or four. Two had moderate chronic GVHD, and two had TMA-requiring treatment. But that’s what we’re hoping for in the future – once we reach a good dose, it’s maybe in the future combined with a lower dose PTCy to lower these side effects. Again, this is a small number of patients and hopefully in the future we’ll have more data and more dose escalation and maybe in the future, combined with a lower dose of PTCy.
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