Na trying to compare chemo with CLTX when used in the same patients would be pointless. There's no clinical assessment between chemo and CLTX either.
The chemo mentioned, flu/cy combination, is commonly used as a lymphodepletion regimen prior to CAR-T therapies making them safer, more effective and longer lasting.
I imagine it wasn't required in the phase 1a because of the delivery route. Now with systemic treatment (IV) it is required.
They may be looking to reduce the requirement for neurosurgeons with the knowhow to perform the intra-cavity and intra-ventricular routes, which CHM has alluded to being a bottleneck. Reducing the number of these visits, even if not to zero, could make it more realistic for the trial and realworld.
There are studies showing some CAR-Ts can cross the BBB and expand in the CNS, so worth trying.
Still, I think its going to take longer than you think before they get it up and going again. Does 1+11 mean they've dosed 1 patient and plan 11 more after the change in protocol is approved? Who knows.
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