Some reading and food for thought leading up to first cohort results on Friday (AU time)... here is a New England Journal of Medicine of the CAR-T that City of Hope licensed off to Mustang Bio i.e. patient Richard Grady. I'm sure some of you have come across this already, but I don't recall it ever being discussed... anyway we've spoken about this case quite a bit, so I think many who haven't seen it will find it an insightful look at the treatment program, his exact diagnosis (a rare form of GBM) and frequency/strength of doses.
NEJM CAR-T City of Hope IL13Ra2What I found interesting is that the dose given to Richard was equivalent to the low dose i.e. 2x10
6 and then 10x10
6 , which as you can see from the below he started off with ICT (directly into the resected tumor), and then from cycle 7 onwards it was ICV (into the cavity within the brain). While this is a totally different treatment, what happened with Richard is that the low dose injected through ICT of the first primary tumor resulted in disease stabilisation for that tumor (tumor 1 in this study). However more tumors formed and those other than tumor 1 continued to progress as well....
So even in this exceptional case (which has been difficult to repeat, and CoH and Mustang don't exactly know why) ... the lowest dose inejcted into the tumor site is probably at best going to result in disease stabilisation. And if we see that, then come cohort two, when injections are administered through both ICT and ICV ... we could see some dramatic results (though again to reiterate, this case with Richard Grady has been an anomaly to date, and I haven't heard of another case since with such a dramatic response).
So it's a very high bar to compare to (i.e. complete response), but it does show that we may be in for some exciting results in 2022... but in the meantime, any signal from the first cohort of our trial will put us right in the box seat to possibly produce some amazing results from the second cohort onward.
You can see how dramatic the change was after the ICV injections, which we will only get to see from the second cohort onwards for our CLTX trial.... that read-out can't come soon enough...but first, they have to fully recruit first.
There is also a nice insight into the type of side-effects he endured through both types of treatments.. which were pretty minor.
(20min delay)