I'm quite new to the IMU story, but few observations (+ inferred implications) and questions on the onCARlytics trial that have not been mentioned.
1. CF33-CD19 is combined with blinatumomab, T cell engager, that has approved indications in hematological diseases. The onCARlytics is the only trial with blinatumomab in clinicaltrials.gov that is focused on solid tumors (that I could find by search). To me it implies that blinatumomab by stand-alone drug has poor "adverse event - efficacy -ratio" against solid tumors in mice models, right?
2. I couldn't find from the trial registration the dose of blinatumomab and how it relates to the dosing in the approved indications, anybody?
3. In the trial registration, the primary outcomes in onCARlytics include "Change in lymphocyte subset expression in tumor tissue and peripheral blood pre and post dose" which isn't as highly prioritized in the MAST trial (not primary or secondary but other outcome category). This is to indicate that combination of CF33-CD19 + blinatumomab induces greater immunological response than CF33-CD19 alone and provides evidence that CF33-CD19 functions in humans as preclinically hypothesized, right? Other rationales?
4. Does somebody know why the onCARlytics combination is studied before CF33-CD19 + Azer-cel combination? Blinatumomab is ofc approved for hematological diseases and there is safety data from this usage, but it has not been previously studied with human solid tumors before, which is the case for Azer-cel, too?
5. If the CF33-CD19 + blinatumomab is safe and immunological response is enhanced, in the future, there could be trial for combo of CF33-CD19 + blinatumomab + Azer-Cel?
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- Ann: Phase 1 onCARlytics Trial Doses First Intravenous Patient
Ann: Phase 1 onCARlytics Trial Doses First Intravenous Patient, page-105
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