Estrella Immunopharma, Inc. (Nasdaq: ESLA, ESLAW), a clinical-stage biopharmaceutical company specializing in ARTEMIS® T-cell therapies targeting CD19 and CD22 for cancer and autoimmune disease treatment, has announced that the first patient in the Phase I/II STARLIGHT-1 clinical trial achieved complete remission (CR) one month after receiving an infusion of EB103 CD19-targeted ARTEMIS® T cells.
In clinical trials, “complete remission” indicates that all tumor target lesions have disappeared, and there are no detectable symptoms or signs of tumors following treatment. The first patient treated in the STARLIGHT-1 clinical trial was diagnosed with follicular lymphoma, presenting with grade 3A high-risk 3B symptoms and had experienced three relapses after multiple failed treatments. Enrolled at the UC Davis Comprehensive Cancer Center, this high-risk patient had a significant tumor burden and multiple comorbidities, making him susceptible to common side effects associated with existing CAR-T therapies, such as severe cytokine release syndrome (CRS) and neurotoxicity. Remarkably, no treatment-related serious adverse events (SAEs) were observed in this patient during the trial.
Dr. Cheng Liu, President and CEO of Estrella Immunopharma, expressed cautious optimism regarding the early results and the favorable safety profile of EB103. “Our goal is to develop ARTEMIS® T-cell therapy that not only matches but also exceeds the efficacy of existing commercial CAR-T therapies while addressing their safety issues. By improving safety, we aim to broaden the patient population that can benefit from T-cell therapy, extending its availability beyond specialized cancer centers to community hospitals.”
Naseem Esteghamat, MD, assistant professor of medicine at UC Davis Comprehensive Cancer Center and principal investigator of the trial, remarked, “The preliminary safety and efficacy results observed in the first patient with this innovative cell therapy, EB103, are very encouraging. We look forward to continuing this clinical trial to further validate the therapy and provide this potentially curative treatment to a larger patient population.”
The STARLIGHT-1 Phase I/II clinical trial is an open-label, dose-escalating study designed to evaluate the safety of EB103 autologous T-cell therapy and determine the recommended Phase II dose (RP2D) in adult patients (≥18 years old) with relapsed/refractory B-cell non-Hodgkin’s lymphoma. The trial consists of a dose-escalation phase followed by an expansion phase. More information about the trial is available at www.clinicaltrials.gov under NCT06343311.
About Estrella Immunopharma
Estrella is a clinical-stage biopharmaceutical company focused on developing ARTEMIS® T-cell therapies targeting CD19 and CD22 for cancer and autoimmune diseases. The company’s mission is to harness the human immune system’s evolutionary potential to enhance the lives of patients battling cancer and other diseases. To achieve this, Estrella is actively advancing its R&D pipeline. The lead product candidate, EB103, employs Eureka’s ARTEMIS® technology to target CD19, a protein present on nearly all B-cell leukemias and lymphomas. Additionally, Estrella is developing EB104, which targets both CD19 and CD22, a protein commonly expressed on most B-cell malignancies.
