On September 19, 2023 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases reported that the first patient has been dosed in the Phase 1/2 trial evaluating IMPT-314, a bispecific CD19/CD20 CAR T-cell therapy for the treatment of relapsed or refractory (R/R) aggressive B-cell lymphoma (Press release, ImmPACT-Bio, SEP 19, 2023, View Source [SID1234635259]).
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"We are pleased to have treated the first patient with IMPT-314 and build on the clinical evidence from the ongoing investigator-led study of this dual-targeted CD19/CD20 CAR T-cell therapy. We believe IMPT-314 may improve tolerability and durability of responses in patients with B-cell lymphomas and therefore has best-in-class potential," said Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio. "Safety and efficacy data from this Phase 1/2 study will determine the recommended Phase 2 dose for IMPT-314 and inform on potential cohort expansion opportunities. We expect to present Phase 1 safety and initial efficacy data from patients with relapsed or refractory aggressive B-cell lymphoma in the first half of 2024."
Sarah Larson, M.D. principal investigator and associate clinical professor of medicine, David Geffen School of Medicine at University of California, Los Angeles added, "While CD19 CAR T-cell therapies have transformed the lymphoma treatment landscape, durability has been limited by treatment resistance due to selective pressure against the target antigen and subsequent loss of expression. We designed this therapy to target both CD19 and CD20 to help restrict antigen escape and ultimately prolong treatment response. We look forward to delineating the differentiated therapeutic potential of this bispecific approach through data from ImmPACT Bio’s Phase 1/2 trial of IMPT-314."
ImmPACT Bio’s Phase 1/2 is a multi-center, open-label clinical trial that will evaluate the safety and efficacy of IMPT-314 in participants with R/R aggressive B-cell lymphoma. The dose-finding Phase 1 portion of the study will include both CAR T-experienced and CAR T-naïve patients.
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.
About B-cell Lymphoma
B-cell lymphomas are a type of blood cancer affecting B cells of the immune system that often relapse and require multiple lines of therapy. In the U.S., approximately 85% of the non-Hodgkin lymphomas (NHL) are a type of B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Despite various approved therapies available, including CD19-targeted CAR T-cell therapies, there remains a significant unmet need for safe and highly efficacious therapies for B-cell lymphomas.
About IMPT-314
IMPT-314 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT Bio’s IMPT-514, which is under development for systemic lupus erythematosus and lupus nephritis. IMPT-314 and IMPT-514 are based on work by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., associate clinical professor, both of the University of California, Los Angeles (UCLA). Initial Phase 1 data from a UCLA investigator-led study evaluating the bispecific CAR construct underlying IMPT-314 demonstrated a 91% (10/11) overall response rate, 73% (8/11) complete response rate, 18.2-month median progression free survival, and a well-tolerated safety profile with no cytokine release syndrome above Grade 1 and no neurotoxicity in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma. IMPT-314 is currently being evaluated in the ongoing Phase 1/2, multi-center, open-label trial in participants with R/R aggressive B-cell lymphoma. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of R/R aggressive B-cell lymphoma.