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Cellular Biomedicine Announces First Patient Dosing in Anti-CD20 Trial

June 20, 2019 By americanpharmaceuticalreview

Cellular Biomedicine Group has initiated its Phase I Clinical Trial of anti-CD20 Chimeric Antigen Receptor T-cell (CAR-T) targeting anti-CD19 treated, relapsed diffuse large B-cell lymphoma (DLBCL) and small B-cell lymphoma patients in China, and dosed the first CD19 CAR-T relapsed DLBCL patient.

"DLBCL is a very aggressive form of lymphoma that advances quickly in both men and women. Based on our research and development, we believe CD20 is a promising target for CD19 CAR-T relapsed and small B-cell lymphoma patients who currently have no viable treatment options," said Tony (Bizuo) Liu, Chief Executive Officer of the Company. "This CD20 CAR-T therapy is one of the multiple assets that CBMG is advancing amongst our oncology-hematology pipeline, which includes anti-BCMA CAR-T targeting relapsed and refractory Multiple Myeloma ("MM"). We continue to enroll MM patients in our anti-BCMA clinical trial."

"We intend to initiate the Alpha Fetoprotein T-cell Receptor (AFP-TCR-T) program and recruit Hepatocellular Carcinoma patients as soon as practicable. As previously announced, we plan to conduct the next generation Tumor Infiltrating Lymphocytes (TIL) for the treatment of non-small cell lung cancer (NSCLC) and other solid tumor indications clinical trials in both the U.S. and in China. Our goal is to provide expeditious, safe and effective therapies to cancer patients who currently have limited treatment options," said Liu.

This Phase I interventional clinical study, conducted in leading clinical centers in China will enroll 12 patients initially to evaluate the safety and efficacy of anti-CD20 CAR-T therapy.

Diffuse Large B-Cell Lymphoma (DLBCL) is the most common form of Non-Hodgkin Lymphoma (NHL) with DLBCL representing approximately 30% of newly diagnosed NHL cases in the United States and an even higher percentage of newly diagnosed NHL cases in China. DLBCL is an aggressive form of lymphoma that advances quickly and occurs in both men and women although slightly more common in men. The incidence of DLBCL increases with age with most patients over the age of 60. The current treatment options include chemotherapy, anti-CD19 targeted therapy, radiation and stem cell transplantation. However, for patients with refractory DLBCL (failed to respond to treatment) the dismal clinical response rates of 20%-30% with median overall survival of approximately 6 months represents a significant unmet medical need.

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