Xenetic Biosciences Announces That Its Collaboration Partner PeriNess Received Israeli Ministry Of Health Approval To Conduct An Exploratory Clinical Study Of Combination Systemic DNase I With Anti-CD19 CAR T Cells In Large B Cell Lymphoma Patients

This approval follows positive preclinical results that demonstrated significant improvement of CAR T cell expansion and persistence and functionality when combined with DNase I. This combination therapy resulted in improved tumor control, delayed relapse and prolonged survival across multiple preclinical models of leukemia and lymphoma.

Under the approved clinical study protocol, 12 LBCL patients with stable or progressive disease prior to lymphodepletion therapy are intended to be treated with CAR T cells targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) in combination with DNase I (50-ml IV infusion dose, 1.0 mg/kg IV on Days 0,3,6,10 and 15 after CAR T cells infusion). Clinical efficacy is intended to be evaluated by the Objective Response Rate (ORR) at 1 and 3 months post CAR T infusion, duration of response (DOR), disease control rate (DCR) and overall survival (OS) at 12 months post CAR T cells infusion. We believe the study has the potential for a translational component with a complex assessment of biomarker response and analysis of anti-CD19 CAR T expansion and persistence.

Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Sourasky Center, has initiated the study as the principal investigator and all work is intended to be conducted at Sourasky Center in Israel.