The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.
Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.
TG Therapeutics (TGTX) is the sponsoring company for this trial. BiotechSign currently grades this company D (37/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.