Therapy Areas: Oncology
CARsgen Therapeutics wins FDA's IND clearance for CT053 for myeloma
20 June 2019 -

Clinical-stage immune-oncology company CARsgen Therapeutics revealed on Wednesday that its BCMA CAR-T cell has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA).

This IND clearance for the company's drug candidate, CT053 fully human BCMA (B-Cell Maturation Antigen)-CAR-T cell, relates to the treatment of patients suffering from relapsed/refractory multiple myeloma (rrMM).

CT053 has received IND clearance from the National Medical Products Administration in China four months ago and is the subject of an ongoing phase I clinical trial.

Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell.

At the 5th Annual Immunotherapy in Myeloma Scientific Workshop in Denver, Colorado, the company provided an update of the clinical data of CT053 showing that 87.5% of the patients showed overall response to the treatment. 70.8% of the patients had complete response and no grade three or higher cytokine release syndrome (CRS) was observed in 24 heavily pre-treated patients with rrMM. The IND clearance of CT053 by the FDA is of great significance to patients, said its founder Dr Zonghai Li.

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