Xenetic Biosciences doses first patient in DNase and CAR T-cell study

Xenetic Biosciences, Inc. (NASDAQ: XBIO) announced that its collaboration partner, PeriNess Ltd., has dosed the first patient in an investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy for large B-cell lymphoma (LBCL) at the Tel Aviv Sourasky University Medical Center in Israel.

The study was approved by the Israeli Ministry of Health and the applicable Institutional Review Board in June 2026. It is enrolling 12 patients with LBCL who have stable or progressive disease prior to lymphodepletion therapy, a population with a one-year progression-free survival of approximately 20% to 30%.

Patients will receive a commercial anti-CD19 CAR T-cell product — tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel — alongside DNase I administered as a 50 mL intravenous infusion at 1.0 mg/kg on days 0, 3, 6, 10, and 15 following CAR T-cell infusion.

The study's primary clinical endpoints include objective response rate at one and three months, duration of response, disease control rate, and overall survival at 12 months. The study also includes a translational component assessing biomarker response and CAR T-cell expansion.

Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the medical center, is serving as principal investigator. "Accumulation of cell-free chromatin and NETs within the tumor microenvironment may contribute to CAR T-cell dysfunction through impaired expansion, exhaustion and immunosuppression," said Dr. Ram. "By targeting these mechanisms with DNase I, we aim to determine whether we can create a more favorable environment for CAR T cells to expand, persist and deliver improved clinical responses."

James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic, said the study marks the first clinical evaluation of the company's systemic DNase technology as an adjunct to CAR T-cell therapy. Information in this article is based on a press release issued by Xenetic Biosciences.

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