The US Food and Drug Administration (FDA) gave clearance to the Investigational New Drug (IND) application for IMPT-314 to treat aggressive B-cell lymphoma, according to a press release from ImmPACT Bio, the developers of the treatment. 

“This IND clearance is a significant milestone for our company,” Sumant Ramachandra, MD, PhD, the president and chief executive officer of ImmPACT Bio, said.

Read more about the treatment of DLBCL

The experimental treatment is currently being tested in an ongoing investigator-led study at the University of California, Los Angeles (UCLA) in patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL). 

Results from the study have shown that 90% of patients had an objective response to the treatment, with 70% achieving a complete response with significant durability of remission. The treatment also demonstrated a favorable safety profile.

These findings suggest that “IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas,” according to Dr. Ramachandra.

The company now plans to initiate a phase 1/2 clinical trial in the first quarter of 2023 to test the experimental treatment in patients with aggressive B-cell lymphoma, including DLBCL. “We look forward to initiating this phase 1/2 trial to help cancer patients who need new therapies,” Dr. Ramachandra said. 

IMPT-314 is a bispecific “OR-Gate” autologous chimeric antigen receptor (CAR) T-cell therapy that targets the B-cell antigens CD19 and CD20. This means that it can recognize tumor cells expressing one or both antigens. 

DLBCL is the most common type of non-Hodgkin lymphoma, with an estimated incidence rate of 4.68 cases per 100,000 per year. Although most patients with DLBCL respond to first-line treatment, around 30% to 40% do not achieve remission or experience a relapse. This leads to a poor prognosis and underscores the need for novel effective treatments for the disease.


ImmPACT Bio announces FDA clearance of IND for novel bispecific CAR to treat aggressive B-cell lymphoma. News release. ImmPACT Bio USA, Inc; January 24, 2023.