Sana Biotechnology announced the FDA had cleared its application to start a clinical trial for its allogeneic, or “off-the-shelf” CAR-T cell therapy targeting the antigen CD19 for patients with B-cell lymphomas and leukemias.
Sana said its therapy, dubbed SC291, was designed to evade the immune system, which could help cell therapy produce a more durable response in patients, a concern that has followed such off-the-shelf therapies that use donor cells as opposed to a patient’s own cells.