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Eden BioCell Doses First Patient in Phase I CAR T-Cell Study

NEW YORK – Ziopharm Oncology said on Monday that the first patient has been dosed in a Phase I trial evaluating autologous, rapid personalized manufacturing (RPM) CD19-specific CAR T cells as a treatment for advanced leukemias and lymphomas.

Manufacturing the CAR T-cell therapy, a product of Ziopharm and TriArm Therapeutics' joint venture Eden BioCell, involves inserting DNA into the genome of patients' harvested T cells such that they co-express chimeric antigen receptor, membrane-bound IL-15. The company uses a non-viral transposon transposase system dubbed Sleeping Beauty to engineer the cells.

The Phase I study's primary aim is to assess the maximum tolerated dose and safety of the treatment for roughly 24 patients with various relapsed, CD19-positive lymphoid malignancies, and the secondary aims will include evaluating the treatment's feasibility and preliminary efficacy. The trial is taking place at the National Taiwan University Hospital.

Ziopharm and Eden BioCell anticipate sharing updates from the trial, including patient characteristics, during the second half of the year. The announcement of the first patient dosed follows the Taiwan Food and Drug Administration's approval of an investigational new drug application for the treatment in December 2020.