Hi Lori. For any trial there are certain criteria that has to be met, some of these will be result of what has been seen previously and protocols are quite black and white due to FDA oversight. For this particular trial I had to have extensive blood work (11 tubes for some 20+ assays, counting cbc and cmp as one each even though each measured multiple items), a bone marrow biopsy, spleen ultrasound, ekg, and a general health review. In all theses they are looking for sufficient evidence to include or exclude. Fortunately, I live near the facility so is typically about a 45 min drive depending on Denver traffic 😒.
Patty noted a bit different in our conversation, but I have been told will be a 72 hour hospital stay for each titration dose - those being at least 3 visits each a week apart, maybe more depending on tolerance. As a phase 1 study they are looking mostly at safely and efficacy of dose as these are the first administrations in humans. Following that it will be administered every 3 weeks with a full day at the clinic.