On October 15, 2026 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing difficult to treat cancers, reported that its collaboration partner, PeriNess Ltd. ("PeriNess"), has informed the Company that the first patient has been dosed in an investigator-initiated clinical study evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma ("LBCL") at the Tel Aviv Sourasky University Medical Center ("Ichilov Center") in Israel.
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The milestone marks the first clinical evaluation of Xenetic’s systemic DNase technology as an adjunct to CAR T-cell therapy. The study, sponsored by the Ichilov Center, was approved by the Israeli Ministry of Health and the applicable Institutional Review Board in June 2026 and is designed to evaluate whether degradation of cell-free chromatin and neutrophil extracellular traps (NETs) can improve CAR T-cell expansion, persistence and clinical response.
The study is enrolling 12 patients with LBCL who have stable or progressive disease prior to lymphodepletion therapy, a population with a historically poor prognosis and 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, in combination with 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.
Clinical efficacy will be evaluated by objective response rate (ORR) at one and three months following CAR T-cell infusion, duration of response (DOR), disease control rate (DCR) and overall survival (OS) at 12 months. The study also includes a translational component designed to assess biomarker response, including circulating cell-free DNA and NET markers, as well as anti-CD19 CAR T-cell expansion and persistence.
Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Ichilov Center, is the principal investigator of the study. "Advancing this approach into patients provides an important opportunity to evaluate this biological hypothesis in a clinical setting," said Dr. Ram. "Accumulation of cell-free chromatin and NETs within the tumor microenvironment may contribute to CAR T-cell dysfunction through impaired expansion, exhaustion and immunosuppression. 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, particularly in patients entering treatment with stable or progressive disease."
"The initiation of this study represents a significant step forward for Xenetic as our systemic DNase technology enters clinical evaluation alongside what we believe to be one of the most important advances in cancer immunotherapy," said James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic. "Our preclinical work has demonstrated the potential for DNase to enhance CAR T-cell expansion, persistence and functionality, improve tumor control, delay relapse and prolong survival across multiple leukemia and lymphoma models. We are pleased to be working with PeriNess and the experienced team at the Ichilov Center and look forward to the continued advancement of the study."
(Press release, Xenetic Biosciences, OCT 15, 2026, View Source [SID1234673491])