The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse large B-cell lymphoma (DLBCL). The most common type of diffuse large B-cell lymphoma is non-Hodgkin’s lymphoma which develops from abnormal B-cells in the lymph nodes, or specific locations in the intestine, bone, brain, or spinal cord. The therapy, C-CAR039, targets both CD19 and CD20 B-cell specific lineage antigens and aims to increase objective and complete response rates in DLBCL, and specifically non-Hodgkin’s lymphoma. Due to the rate of DLBCL progression, the most common therapy used is a combination of chemotherapy and monoclonal antibody rituximab (Rituxan), also known as an R-Chop regimen. CBMG is a US-based biotechnology company that develops innovative cellular immunotherapy treatments for patients with cancer.

 

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