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ImmPact Bio to Begin Phase I/II Trial of Bispecific CAR T-Cell Therapy in Aggressive Lymphoma

NEW YORK – ImmPact Bio on Tuesday said it will begin a Phase I/II clinical trial evaluating its bispecific CAR T-cell therapy, IMPT-314, as a treatment for patients with aggressive B-cell lymphoma.

The US Food and Drug Administration cleared ImmPact's investigational new drug application, giving the West Hills, California-based firm the go-ahead to evaluate IMPT-314 in patients. The trial, which is expected to launch during Q1 2023, will assess the autologous cell therapy's safety and preliminary activity.

The bispecific CAR T-cell therapy is designed to target both the CD19 and CD20 B-cell antigens on the surface of lymphomas, including diffuse large B-cell lymphoma (DLBCL). The therapy is meant to address antigen escape, which is a common reason why patients experience disease relapse after treatment with CD19-targeted therapy.

The treatment is already undergoing an investigator-led trial at the University of California, Los Angeles. In a recent Cancer Discovery paper, researchers published data on the first 10 patients enrolled in this trial and reported that nine patients with non-Hodgkin lymphoma had an objective response to the CAR T-cell therapy and seven experienced a durable complete response. The median progression-free survival time was 18.2 months, and the safety profile was encouraging.

"These initial efficacy results combined with favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas," ImmPact President and CEO Sumant Ramachandra said in a statement.

In January 2022, ImmPact closed a $111 million Series B funding round, which it will use to advance IMPT-314 clinically as well as two other preclinical CAR T-cell therapy programs in solid tumors.