NEW YORK – Gracell Biotechnologies said on Thursday that it has begun a Phase I trial of its autologous CAR T-cell therapy GC012F for B-cell non-Hodgkin's lymphoma.
The Suzhou, China-based firm has dosed multiple relapsed or refractory B-NHL patients with the cell therapy, which is designed to dually target CD19 and the B-cell maturation antigen, or BCMA, on the surface of B-NHL cells. The firm believes that targeting both CD19 and BCMA will improve the treatment's efficacy, since most B-NHL cells express CD19 and an additional 39 percent to 97 percent of clinical samples have also been shown to express BCMA.
The firm developed GC012F using its FasTCAR platform, which it says allows for next-day product manufacturing. According to Gracell, CAR T-cells manufactured on the FasTCAR platform appear less exhausted and better suited to proliferate and persist in the body, including via bone marrow migration. The platform, the firm believes, could improve patient access to CAR T-cell therapies and bring down costs.
Gracell is also evaluating the treatment for relapsed or refractory multiple myeloma patients and received orphan drug designation from the FDA for that indication this past November.