Estrella Immunopharma Treats First Patient with Two EB103 Infusions in STARLIGHT-1 Dose-Expansion Phase
Patient received two infusions three weeks apart at the recommended Phase II dose; no treatment-related serious adverse events observed through the first month of follow-up
EMERYVILLE, Calif., October 15, 2026--Estrella Immunopharma, Inc. (NASDAQ: ESLA) ("Estrella" or the "Company"), a clinical-stage biopharmaceutical company developing CD19- and CD22-targeted ARTEMIS® T-cell therapies to treat cancers and autoimmune diseases, today announced that the first patient who received two infusions, each at 5 × 10⁶ EB103 T cells/kg, three weeks apart, in the dose-expansion phase has tolerated the study drug well in the first month, with no treatment-related serious adverse events (SAEs) reported. STARLIGHT-1 is evaluating EB103, Estrella's investigational CD19-redirected ARTEMIS® T-cell therapy, in patients with relapsed/refractory (R/R) B-cell non-Hodgkin's lymphoma (NHL).
In the dose-escalation portion of the STARLIGHT-1 trial, EB103 demonstrated a 100% complete response (CR) rate at Month 1 in all evaluable patients in the high-dose cohort. Notably, no treatment-related SAEs have been reported among the nine patients treated with EB103 in the dose-escalation phase, the majority of whom presented with high-risk disease. All evaluable Phase I patients without central nervous system (CNS) involvement who achieved a CR remained in CR at the 9-month assessment.
"Administering two full doses of EB103 within three weeks, with no treatment-related serious adverse events observed to date, is an encouraging start to our expansion phase," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "While this is an early result from a single patient, it supports our rationale for evaluating multiple dosing with the goal of potentially delivering deeper responses in the most difficult-to-treat NHL patients, an approach we believe the safety profile observed with EB103 to date allows us to explore. We look forward to enrolling additional patients and to reporting additional efficacy and safety data from the expansion cohort."
The ongoing expansion phase of the Phase I/II clinical trial for EB103 is designed as a multi-center, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in subjects (≥ 18 years of age) who have R/R B-cell NHL. Estrella expects that data from this expansion cohort will be used to inform the pivotal trial strategy for EB103. As of the date of this press release, active clinical sites for the trial are UC Davis Comprehensive Cancer Center, Baylor Scott & White Research Institute, Oregon Health & Science University, University Hospitals Cleveland Medical Center, and Intermountain Health LDS Hospital. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier NCT06343311.