Cellectis : FDA Lifts Clinical Hold On Allogene's Cancer Drug Trial

(RTTNews) - Cellectis said its licensed partner, Allogene Therapeutics Inc. (ALLO) announced that the U.S. Food and Drug Administration has lifted the clinical hold on its cancer drug trial.

Allogene reported that the FDA's 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 in 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 known to undergo rearrangement as part of the natural T cell or B cell maturation process.

The FDA had placed a clinical hold on all five of Allogene's clinical trials on October 7, 2021 following a report of a chromosomal abnormality detected in ALLO-501A CAR+ T-cells from a single patient enrolled in Allogene's ALPHA2 study.

Allogene said Monday that it plans to initiate a Phase 2 pivotal trial of ALLO-501A in relapsed/refractory large B-cell lymphoma mid-year 2022.

Allogene has an exclusive license to Cellectis' technologies for ALLO-715, ALLO-605 (both directed at BCMA) and ALLO-316 (directed at CD70) and holds development and commercial rights for these investigational product candidates.