Hi @actionnaire
The info on the clinical trials site (https://classic.clinicaltrials.gov/ct2/show/NCT06063317) outlines that the shift from monotherapy to combo with Blincyto would be based on RP2D 'Determination of the Recommended Phase 2 Dose (RP2D) to apply to Dose Escalation Combination Phase as supported by immune response as seen in lymphocyte subsets, ... cytokines, ... anti-tumor activity'. IMU announced that the safety committee had OK'd going to the combo but there's no information about lymphocyte subsets, cytokines, or the all-important anti-tumor activity. IMU only mentions safety in the announcement. If the lead-in monotherapy is finished complete with the required data as planned, and that data had to be presented to the SRC, I would very much like to know if CF33-CD19 did in fact express CD19 and do the circulating T Cells reflect this. To answer your question you have no choice other than to assume it's all going as planned because we are not privy to the OASIS data (even though as owners we have paid for it!). I certainly have NFI whether CF33-CD19 is doing as planned.
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