According to Towards Healthcare Study, Estrella Immunopharma, Inc., a clinical-stage biopharmaceutical innovator developing CD19 and CD22-targeted ARTEMIS® T-cell therapies for autoimmune and oncological diseases, has announced outstanding results from the second dose cohort of its Phase 1 STARLIGHT-1 clinical trial evaluating EB103 for the treatment of Advanced B-cell Non-Hodgkin’s Lymphoma (NHL).
The company reported a 100% complete response (CR) rate within one month among all patients treated in this second dose cohort — a remarkable milestone in the treatment of relapsed or refractory (R/R) B-cell NHL, especially among high-risk patients who were ineligible for commercial CD19 therapies, including one participant with Central Nervous System (CNS) lymphoma.
Equally notable, no serious treatment-related adverse events (SAEs) were observed during the trial, underscoring EB103’s favorable safety profile in a population that traditionally faces limited therapeutic options.
About the Second Dose Cohort
The second dose cohort enrolled patients with refractory or relapsed B-cell NHL who had previously failed multiple lines of therapy. Following treatment, a Data and Safety Monitoring Board (DSMB) — an independent expert committee overseeing patient safety and study progress — will review cumulative safety and efficacy data to recommend the Recommended Phase 2 Dose (RP2D) for the next phase of the trial.
The Phase 1/2 STARLIGHT-1 study is a multi-center, open-label, dose-escalation and dose-expansion trial designed to assess both the safety and preliminary efficacy of EB103, an autologous T-cell therapy, in adult patients aged 18 and older with R/R B-cell NHL. Phase 1 focuses on dose escalation and safety evaluation, while Phase 2 aims to explore the therapy’s clinical benefit at the RP2D.
Leadership Remarks
Dr. Cheng Liu, Chief Executive Officer of Estrella Immunopharma, commented on the milestone:
“The completion of the second dose cohort with a 100% CR rate marks a major achievement in our EB103 clinical program. We’re encouraged by the therapy’s excellent safety profile, even in a high-risk patient population — including those with CNS involvement. These findings highlight EB103’s potential as a safe and effective treatment option for patients with limited alternatives. We’re now preparing to advance to the dose extension phase of the STARLIGHT-1 trial.”
Next Steps
Estrella Immunopharma plans to initiate the extension phase of STARLIGHT-1 following DSMB evaluation, moving closer to establishing EB103 as a next-generation T-cell therapy for hard-to-treat hematologic malignancies.
If subsequent phases confirm these early results, EB103 could represent a significant breakthrough in the management of advanced B-cell NHL, potentially redefining therapeutic standards for patients who have exhausted current treatment avenues.
Read Complete News at: https://www.towardshealthcare.com/news/estrella-eb103-phase-1-trial-results
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