Xenetic Biosciences partner gets Israeli approval for lymphoma study

Xenetic Biosciences Inc. (NASDAQ: XBIO) announced that its collaboration partner PeriNess Ltd. received approval from the Israeli Ministry of Health to conduct a clinical study combining DNase I with anti-CD19 CAR T cells in large B-cell lymphoma patients.

The exploratory study will treat 12 patients with stable or progressive disease prior to lymphodepletion therapy. Participants will receive CAR T cells targeting CD19 in combination with DNase I administered through 50-ml IV infusions at 1.0 mg/kg on days 0, 3, 6, 10 and 15 after CAR T cell infusion.

The study will evaluate clinical efficacy through objective response rate at 1 and 3 months post CAR T infusion, duration of response, disease control rate and overall survival at 12 months. Dr. Ron Ram, head of the Bone Marrow Transplantation Unit at Tel-Aviv Sourasky Medical Center, will serve as principal investigator.

According to the company's press release, preclinical results showed significant improvement in CAR T cell expansion, persistence and functionality when combined with DNase I. The combination therapy demonstrated improved tumor control, delayed relapse and prolonged survival across multiple preclinical models of leukemia and lymphoma.

Dr. Ram noted that approximately 50-60% of large B-cell lymphoma patients relapse within the first year after CAR T infusion, with 30-45% relapsing within 3 months. Patients with stable or progressive disease at the time of CAR T infusion have a 1-year progression-free survival rate of approximately 20-30%.

Xenetic Biosciences focuses on advancing immuno-oncology technologies for difficult-to-treat cancers. The company's DNase technology targets neutrophil extracellular traps involved in cancer progression.

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