yep might just be worth highlighting again that the dose into the tumor cavity after resection was the same 44m dose in cohort 2 as it was in cohort 1. The extra 44m dose into the brain cavity results in a 88m total dose, but both injection sites were the low dose used in cohort 1. This was done as a new mode of administration was used in patients in this trial, so they had to be extra cautious.
So achieving a similar outcome using the same dose would be largely expected, but what will be interesting is if adding another mode of administration results in a longer disease stability achieved in this second cohort compared to the first or if a partial or complete response is achieved over time? Time will tell, but disease control at this stage (with patients still undergoing evaluation) with no safety concerns means it is on track.
And secondly is persistence of the CLTX CAR-T is improved (a key barrier for CAR-T) via dual administration, as well as the inhibition of distant tumors forming. We save that one of the patients in cohort one stopped treatment not because the initial tumor site which received the injection progressed.. rather it was a distant tumor that started to form which meant the patient had to cease treatment in cohort 1. My understanding is that that particular patient was recruied into cohort 2, so it will be interesting if they were evaluable and if so that patient journey may be quite interesting across two cohorts.
But now they have passed that with safety dose of 44m, they can now ramp it up to 110m per injection site (total 220m dose in cohort 3) which is their first real dose escalation at each injection site.
It seems they are only aiming to recruit 3 or 4 patients for each cohort.. so if they get the two new sites up and running they will literally be in a position to finish a cohort if one patient is recruited in each site, which is in line with their statement of expecting that all 4 cohorts will be completed this year.
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