Xenetic and PeriNess Report First Patient Dosed in DNase and CAR T-Cell Study
The study at Tel Aviv Sourasky University Medical Center will evaluate systemic recombinant human DNase alongside anti-CD19 CAR T-cell therapy in 12 patients with large B-cell lymphoma.
Xenetic Biosciences, Inc. (NASDAQ:XBIO) said the first patient has been dosed in an investigator-initiated study evaluating systemic recombinant human DNase alongside anti-CD19 CAR T-cell therapy for large B-cell lymphoma. The study is being conducted at Tel Aviv Sourasky University Medical Center, also known as the Ichilov Center, in Israel.
PeriNess Ltd. informed Xenetic of the dosing milestone. The study represents the first clinical evaluation of Xenetic’s systemic DNase technology as an adjunct to CAR T-cell treatment.
Sponsored by the Ichilov Center, the study received approval from Israel’s Ministry of Health and the applicable Institutional Review Board in June 2026. It is designed to assess whether breaking down cell-free chromatin and neutrophil extracellular traps, or NETs, can affect CAR T-cell expansion, persistence and clinical response.
The trial is enrolling 12 patients with large B-cell lymphoma whose disease is stable or progressive before lymphodepletion therapy. The announcement describes this population as having a historically poor prognosis, with one-year progression-free survival of approximately 20% to 30%.
Participants will receive one of three commercial anti-CD19 CAR T-cell products: tisagenlecleucel, axicabtagene ciloleucel or lisocabtagene maraleucel.
DNase I will be given as a 50 mL intravenous infusion at 1.0 mg/kg on Days 0, 3, 6, 10 and 15 after the CAR T-cell infusion.
The clinical assessments include objective response rate at one and three months after CAR T-cell infusion, duration of response, disease control rate and overall survival at 12 months. The study also includes laboratory and translational work examining circulating cell-free DNA, NET markers, and 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 study’s principal investigator. The announcement said the research will examine whether cell-free chromatin and NET accumulation may be associated with impaired CAR T-cell expansion, exhaustion and immunosuppression, and whether DNase I can be used to target those mechanisms.
James Parslow, Xenetic’s Interim Chief Executive Officer and Chief Financial Officer, said the study places the company’s systemic DNase technology into clinical evaluation alongside CAR T-cell therapy. He also referred to preclinical work in leukemia and lymphoma models that examined DNase in relation to CAR T-cell expansion, persistence and functionality, tumour control, relapse and survival.
Xenetic said initial efficacy data are expected in Q2 2027. The announcement did not report clinical efficacy results from the study.
Xenetic describes itself as a biopharmaceutical company developing immuno-oncology technologies for difficult-to-treat cancers. It said its DNase platform is intended to target NETs, which the company states are involved in cancer progression. The company is also focused on advancing systemic DNase as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumours.
The company’s announcement noted that clinical development, regulatory approval, funding, and the ability to achieve successful clinical results remain subject to risks and uncertainties. It also said Xenetic’s forward-looking statements, including those concerning the study and its anticipated results, are based on current expectations.
Xenetic Biosciences announced that PeriNess had informed it that the first patient had been dosed in an investigator-initiated study at the Tel Aviv Sourasky University Medical Center in Israel. The study is evaluating systemic recombinant human DNase in combination with anti-CD19 CAR T-cell therapy in patients with large B-cell lymphoma.
The study is designed to evaluate whether degrading cell-free chromatin and neutrophil extracellular traps can improve CAR T-cell expansion, persistence and clinical response. It is the first clinical evaluation of Xenetic Biosciences’ systemic DNase technology as an adjunct to CAR T-cell therapy.
The study is enrolling 12 patients with large B-cell lymphoma. The patients have stable or progressive disease before lymphodepletion therapy, a population the release describes as having 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. The CAR T-cell treatment is being evaluated in combination with DNase I.
DNase I is 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 using objective response rate at one and three months following CAR T-cell infusion, duration of response, disease control rate and overall survival at 12 months. The study also includes assessments of circulating cell-free DNA, neutrophil extracellular trap markers, and anti-CD19 CAR T-cell expansion and persistence.
The announcement says initial efficacy data are expected in Q2 2027. The release does not provide additional timing for the study’s later assessments.
Dr. Ron Ram, Professor of Medicine and Head of the Bone Marrow Transplantation Unit at the Ichilov Center, is the principal investigator. The study is sponsored by the Ichilov Center and was approved by the Israeli Ministry of Health and the applicable Institutional Review Board in June 2026.
Dr. Ron Ram said that accumulation of cell-free chromatin and neutrophil extracellular traps within the tumour microenvironment may contribute to CAR T-cell dysfunction through impaired expansion, exhaustion and immunosuppression. He said the study aims to determine whether targeting these mechanisms with DNase I can create a more favourable environment for CAR T-cell expansion, persistence and clinical responses.
James Parslow, Interim Chief Executive Officer and Chief Financial Officer of Xenetic Biosciences, said the study represented the company’s systemic DNase technology entering clinical evaluation alongside CAR T-cell therapy. He also said the company’s preclinical work had shown potential for DNase to enhance CAR T-cell expansion, persistence and functionality, improve tumour control, delay relapse and prolong survival across multiple leukemia and lymphoma models.
Xenetic Biosciences, Inc. is a biopharmaceutical company focused on immuno-oncology technologies addressing difficult-to-treat cancers. The company says its proprietary DNase technology is designed to improve outcomes of existing treatments, including immunotherapies, by targeting neutrophil extracellular traps involved in cancer progression.
The source identifies the issuer as Xenetic Biosciences, Inc. (NASDAQ:XBIO).
Xenetic Biosciences says it is focused on advancing its systemic DNase programme into the clinic as an adjunctive therapy for pancreatic carcinoma and locally advanced or metastatic solid tumours. The release also states that the company’s forward-looking statements are subject to risks including clinical-development delays, regulatory issues, funding requirements and uncertainty over clinical results.