NEW YORK – Estrella Biopharma said on Wednesday that the US Food and Drug Administration cleared an investigational new drug application for a Phase I/II trial of its CD19-targeted T-cell therapy, EB103, in patients with B-cell lymphomas.
In the Starlight-1 trial, the Emeryville, California-based company will evaluate safety, tolerability, and preliminary anti-cancer efficacy and determine a recommended Phase II dose in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The trial will include patients with human immunodeficiency virus-associated lymphoma and primary and secondary central nervous system lymphoma.
EB103, dubbed CD19-Redirected Artemis T Cell, is designed to form a multimeric T-cell signaling complex with the T cell upon engaging with the target. In a proof-of-concept study, among 12 patients with B-cell lymphoma, there was an 83 percent overall response rate to the therapy, and 6 patients had a complete response.
"We are thrilled to have received FDA clearance for our IND application for EB103, which will allow us to evaluate it safety and efficacy in a broader range of patients, including those who are typically excluded from other clinical trials, often due to cytokine release syndrome and neurotoxicity," Estrella CEO Cheng Liu said in a statement.