Announcement on submission of the Clinical Trial Plan Notification for phase I/II clinical trial of CAR gene therapy in Japan

On January 11, 2017 Takara Bio Inc. (Takara Bio), reported that it has submitted the Clinical Trial Notification for regenerative medicines to PMDA (Pharmaceuticals and Medical Devices Agency), Japanese regulatory agency, to conduct phase I/II clinical trial for gene therapy using CD19 Chimeric Antigen Receptor (CAR) (Development code: TBI-1501) targeting relapsed and refractory acute lymphoblastic leukemia (ALL) in Japan (Press release, Takara Bio, JAN 10, 2017, View Source [SID1234517405]). In the clinical trial, CAR which recognizes CD19, a protein expressing on the surface of malignant lymphocyte, is transferred ex-vivo to lymphocytes of patients with adult ALL, and the gene-modified lymphocytes are infused back to the patients. The patients will be monitored for safety and efficacy. The Takara Bio’s method of gene transduction and T-cell expansion using RetroNectin, and Takara Bio’s original retroviral vectors for transduction of CD19-CAR will be used during the cell processing for the clinical trial. After the clearance, the protocol will be reviewed by each IRB (Institutional Review Board) and the study will be initiated. Takara Bio aims to commercialize the CD19-CAR gene therapy in the fiscal year 2020, by obtaining an early approval utilizing the conditional and term-limited approval system for regenerative medicines under The Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical devices.

【Overview of the Clinical Trial】
Study name Multicenter Phase I/II Clinical Trial of TBI-1501 for elapsed and refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
Condition Patients with elapsed and refractory CD19-positive B-cell Acute Lymphoblastic Leukemia
Main Endpoint Phase I Clinical trial
1) Safety
2) TBI-1501 Persistency
Phase II Clinical trial
1) Efficacy
Estimated Enrollment 21 (maximum 24)
Duration Mar 2017 – Mar 2020
Site Jichi Medical University and others, total 6 sites

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