On March 13, 2014 Takara Bio reported that its application to conduct clinical research in Japan using CD19 antigen specific CAR (Chimeric Antigen Recepter) gene therapy to target B cell non-Hodgkin Lymphoma, which Takara Bio has been preparing in collaboration with Jichi Medical University, Utsunomiya/Tochigi, Japan, was approved as of March 4th, 2014, by Health Science Council of Japanese Ministry of Health, Labour and Welfare (MHLW).
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CAR gene therapy is one method for ex-vivo gene therapy. In the United States and Europe, many CAR clinical trials targeting Malignant Lymphoma (ML), Acute Lymphocytic Leukemia (ALL), and Chronic Lymphocytic Leukemia (CLL) have been conducted. Since a research team at Memorial Sloan-Kettering Cancer Center (MSKCC; New York, US) reported remarkable efficacies of CD19-CAR gene therapy, it has been actively developed as a promising new cancer therapy. In 2011 Takara Bio and MSKCC executed an agreement, whereby MSKCC would provide its clinical data and materials relevant to the clinical trials of the CD19-CAR gene therapy that MSKCC has been conducting in the United States since 2007, so that Takara Bio and Jichi Medical University could start their planned clinical research in Japan. In this clinical research, Takara Bio will manufacture a GMP-grade CD19-CAR retrovirus vector itself utilizing virus producer cells provided by MSKCC, which will be used for the gene transduction in combination with the RetroNectin reagent, Takara Bio’s efficient gene transduction reagent.
Takara Bio positions the CD19-CAR gene therapy as one of the most important pipelines in its gene therapy portfolio and will accelerate clinical development for it, evaluating its safety and efficacy in this clinical research.
[ Outline of planned clinical research ]
Title Clinical Research of gene therapy for refractory B-cell non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen
Subjects CD19 antigen positive patients with refractory B cell non-Hodgkin Lymphoma
Location of clinical research Jichi Medical University, Utsunomiya/Tochigi, Japan
Method CAR genes that are capable of specifically recognizing CD19 antigens of cancer cells are transduced into the patient’s own lymphocytes obtained from peripheral blood, which are expanded and then re-infused into the patient.
Primary outcomes To evaluate the safety of the CD19-CAR gene therapy
Secondary outcomes To evaluate clinical effect (Anti-tumor effect)
Number of subjects 6 subjects (max. 18)
Trial period To evaluate clinical effect (Anti-tumor effect)