Taking place in China, the trial (ChiCTR1800018900) is aimed at exploring the safety and tolerability of increasing BAT4306F doses in approximately 24 adults with advanced CD20-positive B-cell non-Hodgkin’s lymphoma.
Eligible participants must have received at least one prior line of treatment and have at least one measurable cancer lesion in their lymph nodes or other organ.
“Initiating our Phase 1 clinical trial for BAT4306F represents a major milestone for Bio-Thera Solutions as BAT4306F is our first clinical candidate developed for the treatment of hematologic malignancies,” Shengfeng Li, CEO of Bio-Thera Solutions, said in a press release.
BAT4306F is an investigational man-made antibody designed to target the CD20 protein, which is found at high levels in malignant B-cells. It is similar to approved anti-CD20 antibody Gazyva (obinutuzumab, marketed by Roche), but induces a stronger immune response.
In fact, comparative experimental studies demonstrated that BAT4306F induces a more potent immune response than both Rituxan (rituximab, by Genentech) and Gazyva. In monkeys, a single administration of BAT4306F was much better than either Rituxan or Gazyva at eliminating B-cells in the blood, spleen, and lymph nodes.
“The residual B cells detected in spleen of monkey treated with BAT4306F were 8-fold less than that of obinutuzumab, and 10-fold less than that of rituximab,” the researchers reported.
In the Phase 1 trial, patients will be randomly assigned one of three BAT4306F doses — 500, 1,000, or 1,500 mg — given as an intravenous (into the vein) injection. Each dose will be administered to six patients.
During the trial, researchers will assess the safety profile of the investigational therapy to determine the maximum tolerated dose, dose-limiting toxicity, and optimal dose for future studies.
They will also evaluate immune responses, the behavior of BAT4306F once inside the body, and early signs of effectiveness, including overall response rate and time to disease progression.
“While the BAT4306F development plan will be initially focused on CD20-positive B-cell non-Hodgkin’s lymphoma we believe BAT4306F also has great potential as a treatment for other hematologic malignancies,” Shengfeng Li said.