I noticed that there are a couple of changes in the...

I noticed that there are a couple of changes in the clinicaltrials.gov listing for the phase 1 trial CLTX CAR-T Therapy on GBM patients (https://clinicaltrials.gov/ct2/show/record/NCT04214392). There are a couple of additions:

1. Addition of a second intervention arm - this arm includes two infusion sites in the brain (1 at the site of resection of tumor and 1 at the lateral ventricle) - this seems to be for cohorts 2-4 which includes the introduction of the intraventricular infusion.

3. The increase of MMP2+ tumor expression percentage to 20%. The inclusion criteria is not usually changed unless they're seeing something in the data. They could be seeing less response in patients under 20% MMP2+ expression compared to patients with >20% MMP2+ expression. Not sure if any other reasons, but if anyone knows of any please let me know.

4. The trial was changed from a Single Group Assignment to a Sequential Assignment. This is the first time I've seen this, but from what I've read, it allows patients from Cohort 1 who do not receive any benefit from the intratumoral or intracavitary infusion of CLTX CAR-T, to be re-assigned to Cohort 2,3,4 treatment arms (please let me know if this is correct - https://aacrjournals.org/clincancerres/article/24/4/730/81093/Sequential-Multiple-Assignment-Randomized-Trial). Again, I don't think the option will be opened unless they have seen any benefit in cohorts 2-4 which uses the dual infusion through the resection site and lateral ventricle. If there were no benefits, ethics committees would reject this protocol amendment. Quite interesting.