Estrella Immunopharma announced that the first patient treated in its Phase 1/2 STARLIGHT-1 clinical trial (NCT06343311) evaluating EB103, an investigational autologous CD19-targeted T-cell therapy, achieved a complete response (CR). The trial is focused on patients with B-cell lymphomas. This early result suggests a promising avenue for patients with relapsed or refractory disease.
The patient, diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms, had relapsed three times after prior treatments. The treatment was administered at UC Davis Comprehensive Cancer Center. The patient's condition was considered high-risk due to high tumor burden and multiple comorbidities, factors that often increase the risk of adverse events (AEs) like cytokine release syndrome (CRS) and neurotoxicity with existing CAR-T therapies. Notably, the patient experienced no treatment-related serious AEs following EB103 administration.
ARTEMIS Technology
EB103 leverages the ARTEMIS technology developed by Eureka Therapeutics, Estrella's parent company. ARTEMIS differs from traditional CAR-T technology by activating T-cells through a pathway more akin to endogenous T-cell receptors. ARTEMIS T-cells can target intracellular cancer-specific antigens, in addition to the surface antigens typically targeted by CAR-T therapies.
Management Commentary
"We are cautiously optimistic about these early results and the favorable safety profile of EB103 observed in our first treated patient of this clinical trial," said Cheng Liu, PhD, president and chief executive officer at Estrella. "Our goal is to develop ARTEMIS T-cell therapies that not only match but also surpass the efficacy of commercially available CAR-T therapies, while also addressing their safety shortcomings. By improving safety, we hope to reach a broader patient population and make T-cell therapy accessible in community hospitals, not just specialized cancer centers."
STARLIGHT-1 Trial Details
The open-label, multicenter STARLIGHT-1 trial is a dose escalation and expansion study for patients aged 18 years and older with histologically confirmed relapsed/refractory B-cell NHL. The IND allows for inclusion of patients with HIV-associated lymphoma and primary and secondary central nervous system lymphoma. UC Davis Comprehensive Cancer Center is currently the only recruiting location, with Naseem Esteghamat, MD, serving as the principal investigator.
Expert Opinion
"CAR-T therapies have improved outcomes for patients with B-cell non-Hodgkin lymphomas (NHLs) compared with traditional standard-of-care treatments," said Mehrdad Abedi, MD, a professor of medicine at UC Davis Comprehensive Cancer Center. "However, patients battling relapsed/refractory (r/r) NHL, especially those with high-risk conditions such as HIV-associated lymphoma, central nervous system lymphoma, and additional high-grade NHL subtypes urgently need new therapeutic options that minimize the risk of potential life-threatening side effects, including severe CRS and neurotoxicity. EB103 ARTEMIS T-cell therapy represents an innovative treatment option that may potentially benefit a wider range of r/r B-cell NHL patients."
