FDA Lifts Clinical Hold On Allogene's CAR-T Trials

The FDA has lifted the hold on Cellectis SA's CLLS licensed partner, Allogene Therapeutics Inc ALLO clinical trials.

• The agency had placed a clinical hold on all five of Allogene's trials following a report of a chromosomal abnormality detected in ALLO-501A CAR+ T-cells from a single patient enrolled in Allogene's ALPHA2 study. 
• The investigations concluded that the chromosomal abnormality was unrelated to TALEN gene editing or Allogene's manufacturing process and had no clinical significance. 
• The abnormality was not detected in any manufactured AlloCAR T product or any other patient treated with the same ALLO-501A lot. 
• The abnormality occurred in the patient after the cell product was administered. It involved regions of the T cell receptor and immunoglobulin genes that undergo rearrangement as part of the natural T cell or B cell maturation process.
• Allogene also announced that following the lift of the clinical holds and pending final discussions with the FDA, Allogene intends to initiate a Phase 2 pivotal trial of ALLO-501A in relapsed/refractory large B-cell lymphoma mid-year 2022.
• Price Action: ALLO shares are up 2.87% at $12.55 during the premarket session on the last check Tuesday.