Estrella Immunopharma has achieved a significant milestone in its STARLIGHT-1 Phase I/II clinical trial, announcing successful completion of the first dose cohort evaluating EB103, their novel CD19-targeted ARTEMIS® T-cell therapy. The Data and Safety Monitoring Board (DSMB) has given approval to proceed with the second dose cohort following review of initial safety and efficacy data.
The trial, focusing on patients with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have exhausted multiple treatment options, has yielded encouraging preliminary results. The first cohort demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs) or treatment-related serious adverse events (SAEs). Notably, all patients showed tumor response at the one-month evaluation point.
Trial Design and Next Steps
The STARLIGHT-1 study employs an open-label, dose-escalation, multi-center design following a standard 3+3 protocol. The upcoming second cohort will receive an increased dose of 5 million receptor-positive T cells per kilogram of body weight. This escalation aims to further evaluate EB103's safety profile and determine the optimal dosing for Phase II.
"The safety and early efficacy data from the first dose cohort are encouraging. We look forward to evaluating the higher dose cohort to further understand the potential of EB103 as a transformative therapy for patients with relapsed/refractory B-cell NHL," stated Cheng Liu, Ph.D., President and CEO of Estrella Immunopharma.
Innovative Technology Platform
EB103 represents a novel approach to T-cell therapy, utilizing the ARTEMIS® technology licensed from Eureka Therapeutics. Unlike traditional CAR-T cells, ARTEMIS® T-cells employ a mechanism that more closely mimics natural T-cell receptor activation and regulation when engaging cancer targets. The therapy specifically targets CD19-positive cancer cells, binding to and eliminating them upon infusion.
Therapeutic Implications
The preliminary findings from this trial are particularly significant given the challenging nature of treating relapsed/refractory B-cell NHL. The absence of serious adverse events and early signs of tumor response suggest potential advantages over existing treatments. This early safety profile could be particularly important for patients who have exhausted other therapeutic options.
The trial's progression to a higher dose cohort marks an important step in establishing EB103's potential role in the treatment landscape for B-cell lymphomas. As the study advances, it will continue to evaluate both safety parameters and efficacy measures while determining the optimal dosing strategy for future development phases.
