Hello.

My name is Carolina Schinke. I'm one of the faculty members at the University of Arkansas for medical sciences and work primarily in multiple myeloma.

So I'm very excited to be here. And that’s why I’m at ASH and present our work on ICAHT, which is cytokines, immune-associated cytopenia in patients who undergo immune treatment, particularly CAR T-cell treatment.

And our work is more not just on evaluating these patients, but also looking at what can be done to mitigate these cytopenias. So what we have done in the past is to give them a stem cell boost, which is infusing them stem cells similarly to how we do after stem cell transplant.

Obviously, we don't give the chemo, so there's really no side effect to it. It's just the stem cells that are being infused.

And this is part of the work we're going to present here.

So first of all, this ICAHT stands for cytotoxicity conferred by these immune treatments on the cell counts. So a lot of patients will have cytopenia after CAR-T cell treatment. And sometimes this cytopenia is actually very severe. It's so severe that patients have to come in weekly for growth factor shots or for transfusions.

And so though the myeloma is gone, hopefully in remission, the patients are still experiencing quite a lot of morbidity due to a lot of visits and, yeah, sometimes side effects from low blood counts, which are infections, bleeding, or requirements of transfusions.

First of all, we looked at how often that happens. We see that early on, within 21 days after CAR-T cell infusion, we see it in 60% of patients. And again, that was done in our patient population. This is all off trial. This is sort of what we've seen in real world data.

And we did that in collaboration with another university medical, College of Wisconsin, over 159 patients, and 89 of those. So, almost 60% of patients developed cytopenia 21 days after CAR-T.

Over time, these cytopenias can improve. But we see that in 17% of patients, they're still persisting up until six months. So this is a really long time frame where we have patients coming in with clinically significant cytopenias.

So factors that really predispose patients to develop ICAHT in our work really divided into three categories. First of all, it really depends on how much treatment patients have had before. So a lot of transplants, a lot of lines of treatment, low bone marrow reserve would predispose patients to develop cytopenia post CAR-T.

So if you're receiving CAR-T in very late lines, there's a good chance that you know you will have cytopenias after CAR-T. The other thing we found is that patients who have high risk disease, by FISH or by PET scan, also tend to have a little bit more cytopenias. Yes, a higher risk of ICAHT after CAR-T.

And then, the last thing is also patients who develop severe ICAHT, neurotoxic after CAR-T or acquired tislelizumab. These were all factors that promoted the development of ICAHT or cytopenia after CAR-T.

When we look at those patients that received a stem cell boost, not all patients with cytopenia may need a stem cell. Some will actually recover, but those that had the most severe cytopenia. So really low blood counts after CAR-T where they required to come in a lot and, you know, receive transfusions, growth factors, those were given the stem cell boosts by the treating physician.

And what we see is that the counts recover really nicely with stem cell boost. So from 21 days after CAR-T to three months, we had a robust, prompt and durable count recovery, and that lasted up until six months.

So, we think that this is very effective to improve the counts. And in that way, probably can also mitigate things like infections or requirement of transfusions.

When we look at what are the outcomes of our patient populations that we looked at, 12-month progression-free survival was 67%. Overall survival was 88%. So pretty much in line with what has been reported, and factors that influence outcome were really more intrinsic to myeloma disease.

So high risk myeloma, extramedullary disease is, aggressive diseases that tend to have an adverse impact on outcome. But we did not see any adverse impact, you know, off stem cell infusion, on outcome. So we think it's very safe. And certainly helps patients to recover counts.

And we think that it might even improve outcomes because patients will have better counts, less side effects due to low counts.

So we're very excited about this data and, yeah, I want to encourage patients and the providers, to consider having stem cells in the bank before they go to CAR-T cell treatment, to treat these cytopenias if they're very severe.

So these are things we didn't really measure. It was all retrospectively. So we don't really have raw data for that. But obviously, yes, slightly. Now hypothetically, yes, it improves quality of life.

And again, we think that it also improves, you know, eventually can improve outcomes. Because what we see a lot of times when patients are very low blood counts and then, you know, relapse over time, they cannot receive more treatment because the counts are just too low.

So you really, with giving them a stem cell boost and rescuing these blood counts. It's really a win-win situation.