The US Food and Drug Administration (FDA) has granted clearance for Estrella Biopharma’s investigational new drug (IND) application for the Phase I/II Starlight-1 clinical trial of EB103 to treat B-Cell Lymphoma patients.
The trial of EB103, a T-cell therapy targeting CD19, is designed for the treatment of patients with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), including those with some of the highest unmet medical needs.
They include individuals with human immunodeficiency virus (HIV)-associated lymphoma, and primary and secondary central nervous system (CNS) lymphoma.
Starlight-1 will evaluate the tolerability, preliminary anti-cancer activity, safety, and recommended Phase II dose (RP2D) of EB103 to treat patients with R/R B-cell NHL.
The trial is expected to commence in the second half of this year, with initial participant enrolment anticipated to start at UC Davis Health.
Estrella Biopharma president and CEO Dr Cheng Liu said: “We are thrilled to have received FDA clearance for our IND application for EB103, which will allow us to evaluate its 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 (CRS) and neurotoxicity.
“Our goal is to develop a safe and effective therapy that can help address the unmet medical needs of patients with R/R B-cell malignancies, including those who are currently underserved by existing therapies.”
The company’s lead product candidate EB103 uses the ARTEMIS technology of Eureka Therapeutics to target CD19, which is a protein that is expressed on the surface of almost all B-cell leukaemias and lymphomas.
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