Allogene Therapeutics is launching what it calls the first pivotal Phase II trial of an allogeneic CAR T product in the industry. The ALPHA2 trial will evaluate ALLO-501A in relapsed/refractory large B-cell lymphoma (LBCL). In addition to the ALPHA2 trial, the company is working to initiate the EXPAND trial to evaluate the effects of ALLO-647 when added to the standard fludarabine/cyclophosphamide lymphodepletion treatment regimen.
Allogene is attempting to develop an allogeneic CAR T therapy, sometimes referred to as off-the-shelf. One of the downsides of autologous cell therapies is they are labor-intensive, time-consuming, and expensive. In contrast, an allogeneic CAR T product draws on a variety of healthy donors’ T-cells, which are then engineered to express CARs, then further engineered to decrease the risk of graft-vs-host disease (GVHD) and allogeneic rejection. The product can be stored off the shelf for use as needed.
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