University Hospitals (UH) Seidman Cancer Center hematologist-oncologist Leland Metheny, MD, is leading the trial. He says in the two years since the foundational pre-clinical work was completed, the team has shown that it's feasible to manufacture BAFF CAR T-cells for human subjects. The innovation is introducing genes into T-cells via the process of electroporation in the Wesley Center for Immunotherapy at UH Seidman Cancer Center.

In January 2022, a research team from UH Seidman Cancer Center and Case Western Reserve University published a groundbreaking report in the journal Nature Communications, detailing a novel approach to chimeric antigen receptor (CAR) T-cell therapy for B-cell cancers. The new B-cell activating factor (BAFF) CAR T product, developed by UH Seidman Cancer Center and Case Western Reserve University scientist Reshmi Parameswaran, MS, PhD, and colleagues, binds specifically to each of three receptors instead of one – BAFF-R, BCMA and TACI, providing more therapeutic options and guarding against the problem of antigen escape currently found in CAR T therapies that solely target CD19. Experimental results showed that the BAFF CAR T is effective at killing multiple B-cell cancers, with robust in vitro and in vivo cytotoxicity exerted by BAFF CAR T-cells against mantle cell lymphoma, multiple myeloma and acute lymphoblastic leukemia xenograft mouse models.

Now just two short years later, these crucial findings are the basis for the Phase I BAFF CAR T clini.