Cellular Biomedicine Group Inc. announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel autologous bi-specific CAR-T therapy targeting both CD19 and CD20 antigens, both Regenerative Medicine Advanced Therapy (RMAT) Designation and Fast Track Designation for the treatment of patients with relapsed or refractory diffuse large B cell lymphoma (r/r DLBCL).
"This is great news for CBMG that the FDA has granted C-CAR039 both RMAT and fast track designations based on its potential to increase objective and complete response rates in r/r DLBCL. The clinical data based on our clinical trials in China continue to support the hypothesis that C-CAR039 is the best-in-class CAR-T asset for patients in this indication. We are working towards initiating 1b/2 trials for C-CAR039 in the US soon. And we will work closely with the FDA to seek the best path forward to deliver the drug to patients in the US and EU," said Tony (Bizuo) Liu, Chairman and CEO.
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