On November 3, 2025 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 cancer and autoimmune diseases, reported the successful completion of the second dose cohort in Phase I portion of its STARLIGHT-1 Phase I/II clinical trial of EB103, a CD19-redirected ARTEMIS T-cell therapy to treat patients with Advanced B-Cell Non-Hodgkin’s Lymphomas (NHL).
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Key Findings:
The study has achieved a 100% complete response (CR) rate at Month 1 in all evaluable patients treated in the second dose cohort.
All patients treated are considered high-risk group who are not suitable to receive commercial CD19 products, including one with Central Nervous System (CNS) lymphoma. No treatment-related serious adverse events (SAEs) were reported during this study phase.
"Completing the second dose cohort with a 100% CR rate marks a significant milestone in our EB103 clinical program," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "We’re especially encouraged by the favorable safety profile observed in this high-risk group, including a CNS-involved patient, which demonstrates the potential of EB103 as a safe and effective treatment for a broader population of cancer patients who have limited options. We look forward to taking EB103 into the dose expansion phase of STARLIGHT-1."
The second dose cohort included patients with relapsed/refractory B-cell NHL who have failed multiple prior lines of therapy. Following the completion of this dose cohort, a Data and Safety Monitoring Board (DSMB) will review the cumulative study data to evaluate the safety and efficacy of EB103, and to determine the Recommended Phase II Dose (RP2D) for the expansion phase. The DSMB is an independent group of experts that assesses the study’s progress and makes recommendations to the trial’s sponsor.
The Phase I/II clinical trial for EB103 is an open-label, dose escalation, multi-center, Phase I/II clinical trial to assess the safety of EB103 autologous T-cell therapy and to determine RP2D in adult subjects (≥ 18 years of age) who have relapsed/refractory (R/R) B-cell NHL. The study includes a dose escalation phase followed by an expansion phase. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06343311.
About EB103
EB103, a T-cell therapy, also referred to as Estrella’s "CD19-Redirected ARTEMIS T-Cell Therapy," utilizes ARTEMIS technology licensed from Eureka Therapeutics, Inc. ("Eureka"), Estrella’s parent company. Unlike a traditional CAR-T cell, the unique design of an ARTEMIS T-Cell, like EB103 T-cell, allows it to be activated and regulated upon engagement with cancer targets that use a cellular mechanism more closely resembling the one from an endogenous T-cell receptor. Once infused, EB103 T cells bind to and destroy CD19-positive cancer cells.
(Press release, Estrella Biopharma, NOV 3, 2025, View Source [SID1234659309])