The company is seeking people with large granular lymphocyte leukemia (LGL) or refractory cutaneous T-cell lymphoma (CTCL).
BNZ-1 is known as a multi-cytokine inhibitor because it blocks several signaling molecules, or cytokines, that contribute to the progression of immune T-cell blood cancers like LGL and CTCL. These molecules include interleukin (IL)-2, IL-9, and IL-15.
“Together with our investigators, we are eager to characterize the potential clinical benefit of BNZ-1 in patients with LGL or rCTCL,” Paul Frohna, Bioniz’s chief medical officer, said in a press release. “Evaluating BNZ-1 in these patients serves as an important first step in our efforts to characterize the potential of BNZ-1 across a wide range of T-cell malignancies.”
The Phase 1/2 trial (NCT03239392) will evaluate the safety of ascending BNZ-1 doses in up to 24 patients with LGL or CTCL. Researchers will also look at the therapy’s preliminary cancer-countering activity.
Participants will receive weekly intravenous infusions of BNZ-1 for four weeks, after which researchers will assess how safe it was — the trial’s primary goal. The patients will then have three additional months of treatment to further examine the medicine’s safety and ability to respond to cancer.
Researchers are enrolling participants at the Ohio State University, University of Virginia, Moffitt Cancer Center, and City of Hope Cancer Center. Additional information is available at the trial’s registry page.
“BNZ-1 holds great potential as a new therapy for LGL and relapsed CTCL as its novel mechanism of action addresses a critical driver in both these diseases,” said Jonathan Brammer, a hematologist at Ohio State’s James Cancer Center who is the trial’s lead investigator. “The results from this study will help determine if BNZ‑1 has promise as a new treatment option for patients who currently have no or few alternatives.”
It is the only active U.S. study specifically designed to target LGL, he said.