Hi, I am Yi Lin from Mayo Clinic and I'm here at EHA 2025.
To share with you some of the data that we will be presenting from analysis from cartitude clinical trials using cilta-cel to cell in patients with relapsed refractory multiple myeloma.
So we do know from ASCO this year very exciting data presented that from the first cartitude-1 clinical trial in patients in late line therapy for myeloma, those who received cilta-cel close to one third of the patients have remained in remission more than five years out.
So that's very exciting results to see.
But what we also know is that with this particular CAR-T, we can see some uncommon side effects that could have serious manifestations, and that would be with IEC immune effector cell.
So CAR-T cell associated cranial nerve palsy or parkinsonism.
And these typically come on after close to the end of months one after infusion up to about six months being the most common time frame.
Other months two months three is where we see the most common presentation.
And these are times when patients have returned home, and are being followed by their local hematologist oncologist.
So that's a side effect that's very important to recognize early, for early intervention to potentially reduce the symptoms.
So what we wanted to learn is how can we identify the risk factors.
And are there ways we can reduce, the likelihood of this to occur?
Now, what we have seen with the earlier study is these can be on average, up to 4% of the patients.
But just by reducing myeloma disease burden at the time of CAR-T infusion, the risk can go down to 2% or less.
So we wanted to identify associated factor to potentially reduce that risk further.
And what we have seen across the cartitude clinical trial.
So both cartitude-1 and cartitude-4 and two which are done in earlier line therapies, the expansion of the lymphocyte count in the first two weeks, which correspond to the expansion of CAR T-cells.
It's a strongest associated risk factor for developing these neurotoxicity.
Later, we saw that in a cartitude trials.
We also saw that in the real world, experience at Mayo Clinic with patients who received FDA approved CAR-T.
So we're hoping to use that information to say, okay, if these are the patients who would be at increased risk, other thing that could be done during that early time period to further reduce the risk factor.
So we and many centers across the US, as well as in the clinical trials for cilta-cel a currently trying a very short duration, of course three days or so of steroid to see if by reducing that expansion of the CAR T-cells at that time, would it help reduce the risk of these late neurotoxicity.
So that is something that we'll need to wait and see and hopefully be able to share at upcoming Congresses.
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