Pharma Focus Europe

The Initial Dosing of IMPT-314 Commences in Phase 1/2 Study Investigating a Bispecific CD19/CD20 CAR T-cell Therapy for the Management of Aggressive B-cell Lymphoma

Wednesday, September 20, 2023

ImmPACT Bio USA, Inc. (ImmPACT Bio) has initiated a Phase 1/2 clinical trial for IMPT-314, a novel bispecific CD19/CD20 CAR T-cell therapy designed to treat relapsed or refractory (R/R) aggressive B-cell lymphoma. The company recently announced the dosing of the first patient in this study.

Dr. Jonathan Benjamin, Chief Medical Officer of ImmPACT Bio, expressed optimism about IMPT-314, highlighting its potential to enhance patient responses and tolerability. The ongoing Phase 1/2 trial aims to provide crucial safety and efficacy data for IMPT-314, with a focus on determining the recommended Phase 2 dosage and exploring potential expansion opportunities. Preliminary findings from patients with R/R aggressive B-cell lymphoma are expected to be presented in the first half of 2024.

Dr. Sarah Larson, Principal Investigator and Associate Clinical Professor at the David Geffen School of Medicine at the University of California, Los Angeles, explained the rationale behind IMPT-314. She noted that while CD19 CAR T-cell therapies have made significant advancements in lymphoma treatment, treatment resistance can limit their long-term effectiveness due to antigen escape and loss of expression. IMPT-314, with its dual targeting of CD19 and CD20, aims to mitigate these issues and extend treatment responses.

ImmPACT Bio's Phase 1/2 trial is a multi-center, open-label study evaluating IMPT-314's safety and efficacy in patients with R/R aggressive B-cell lymphoma, including both CAR T-experienced and CAR T-naïve individuals. Notably, IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R aggressive B-cell lymphoma.

B-cell lymphomas, a category of blood cancers affecting B cells of the immune system, often necessitate multiple lines of therapy due to relapse. Approximately 85% of non-Hodgkin lymphomas (NHL) in the U.S. are B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Despite available therapies, there is still a significant need for safer and more effective treatments for these conditions.

IMPT-314 is a chimeric antigen receptor (CAR) T-cell therapy that targets both CD19 and CD20, utilizing a potent bispecific CAR and a 4-1BB costimulatory domain. This construct is similar to ImmPACT Bio's IMPT-514, which is in development for systemic lupus erythematosus and lupus nephritis. Early Phase 1 data from an investigator-led study at UCLA demonstrated promising results, including an overall response rate of 91%, a complete response rate of 73%, and a median progression-free survival of 18.2 months, with a well-tolerated safety profile. IMPT-314 is currently undergoing evaluation in the Phase 1/2 clinical trial for R/R aggressive B-cell lymphoma, and it has also received Fast Track Designation from the FDA for this indication.

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