The clinical update summarized the results for 15 B-ALL subjects (4 children and 11 adults) infused with a single dose of HLA-matched or partially matched CAR-CIK CD19 cells manufactured from allogeneic peripheral blood donor cells. Following lymphodepletion and subsequent infusion, the CAR-CIK CD19 cells expanded reaching up to 70% of CAR+ T cells in the peripheral blood. Persistence of central memory CAR+ T cells was reported to be measurable up to 9 months after infusion. Of the 9 patients receiving the highest dose levels, 7 (78%) achieved complete remission at day 28 post-infusion. Six of the 7 CRs (86%) achieved minimal residual disease status. Dr. Magnani reported a high profile of safety in all treated patients with only grade 1 or 2 cytokine release syndrome at the highest dose level and no incidence of graft-versus-host disease, neurotoxicity, or dose-limiting toxicity.
“We are very pleased to continue to observe strong efficacy without serious adverse events and we look forward to continuing our collaboration with CoImmune to further advance the clinical development of this promising technology,” stated study leader, Dr. Andrea Biondi.
“All of us at CoImmune are very excited by the work we are doing with our colleagues in Italy. We are planning additional clinical trials to be conducted in the United States and Italy targeting B-ALL, chronic lymphocytic leukemia, non-Hodgkin’s lymphoma and acute myelogenous leukemia,” said Charles Nicolette, Chief Executive Officer of CoImmune.
About CoImmune, Inc.
CoImmune is a privately held clinical stage biotechnology company specializing in the development of immuno-oncology therapies based on its two proprietary platform technologies. Its autologous RNA-loaded dendritic cell technology platform for solid tumors specifically targets each patient’s unique tumor antigens; its allogeneic CAR-CIK technology platform is a variation on CAR-T therapy with greatly reduced toxicity while retaining strong efficacy.