NEW YORK – ImmPact Bio said on Tuesday that it has treated the first B-cell lymphoma patient in a Phase I/II trial of its CAR T-cell therapy IMPT-314.
Through the Phase I/II trial, ImmPact is studying the safety and efficacy of the autologous, bispecific CD19/CD20-directed CAR T-cell therapy in 50 patients with relapsed or refractory aggressive B-cell lymphoma. To be eligible for the trial, patients must have received at least two prior lines of therapy, including an anti-CD20 monoclonal antibody and an anthracycline-containing chemotherapy regimen.
IMPT-314 is designed to limit antigen escape and serious adverse events, which have historically been associated with autologous CD19-directed CAR T-cell therapies. To accomplish this, ImmPact uses a bispecific CAR and a 4-1BB costimulatory domain. The firm is also studying a therapy with this same construct, IMPT-514, as a treatment for patients with refractory systemic lupus erythematosus.
The lymphoma cell therapy has fast-track designation from the US Food and Drug Administration, and ImmPACT expects to report Phase I safety and initial efficacy data during the first half of 2024.
In January 2022, ImmPact raised $111 million in a Series B funding round, which it said it would put toward advancing IMPT-314 as well as two other preclinical CAR T-cell therapy programs in solid tumors.
"We believe IMPT-314 may improve tolerability and durability of responses in patients with B-cell lymphomas and therefore has best-in-class potential," ImmPact Bio Chief Medical Officer Jonathan Benjamin said in a statement. "Safety and efficacy data from this Phase I/II study will determine the recommended Phase II dose for IMPT-314 and inform on potential cohort expansion opportunities."