NEW YORK – The Taiwan Food and Drug Administration has cleared an investigational new drug application allowing Eden BioCell to begin a Phase I clinical trial to evaluate its autologous CD19-specific CAR T-cell therapy in relapsed CD19-positive leukemias and lymphomas, Ziopharm Oncology said on Monday.
Chinese firm Eden BioCell is a joint venture between Ziopharm, headquartered in Boston, and cell therapy firm TriArm Therapeutics. The CD-19-specific CAR T-cell therapy to be studied in the Phase I trial uses Ziopharm's Rapid Personalized Manufacturing (RPM) technology. The trial, to be conducted at the National Taiwan University Hospital, is the first study of an autologous, non-viral CD19-specific CAR T-cell treatment in Taiwan, according to Ziopharm.
The Phase I trial will enroll up to 24 patients with relapsed CD19-positive leukemias and lymphomas, and researchers will aim to infuse 16 patients with CAR T cells. The primary goal is to evaluate the safety and tolerability of the CD19-specific T cells manufactured using RPM.
The RPM process inserts stable, non-viral DNA into the genome of T cells to co-express chimeric antigen receptor, membrane-bound IL-15, as well as a safety switch in case patients experience adverse events.
"The learnings from this study will build upon the encouraging early data we are seeing with patients treated with RPM CAR T targeting CD19 malignancies under compassionate use," TriArm CEO and Co-founder Jay Zhang said in a statement. "We believe our approach has the potential to transform CAR T therapy by dramatically decreasing the amount of time needed for manufacturing engineered T cells, thereby increasing efficacy and decreasing cost."