Estrella Immunopharma, Inc., a leading clinical-level biopharmaceutical company establishing CD19 and CD22-focused ARTEMIS® T-cell therapies to provide treatment to autoimmune and cancer diseases, declared the completion of its second dose associate in the Phase 1 portion of its STARLIGHT-1 Phase 1/2 clinical trial of EB103. This trial is a CD19-reassociated ARTEMIS® T-cell therapy to offer treatment to Advanced B-cell Non-Hodgkin’s Lymphoma (NHL) patients. The major findings of this study have gained a positive complete response.
The key findings of this study involve a 100% complete response (CR) rate in one month, with every patient receiving treatment in the second dose association. All the patients treated under the second dose cohort are counted in the high-risk group who are not eligible to receive commercial CD19 products, involving one patient with Central Nervous System (CNS) lymphoma. During this study period, no such treatment-based serious adverse events (SAEs) were addressed.
The second dose cohort gathered patients suffering from refractory/relapsed B-cell NHL who have faced failure in various before lines of therapy. A Data and Safety Monitoring Board (DSMB) will check the cumulative study data of this completed dose cohort to further examine the efficacy and safety of EB103 and to go ahead with the Recommended Phase 2 Dose (RP2D) for the extension phase.
The DSMB is an independent and confident team of experts that inspects the study’s progress and offers recommendations to the specific trial’s sponsor. The Phase 1/2 clinical trial for EB103 is a multi-centre, open-label, dose-inspected Phase 1/2 clinical trial to examine the safety of EB103 autologous T-cell therapy and to empower RP2D in adults group >18 years or age who are suffering from refractory/relapsed (R/R) B-cell NHL. The study involves a dose escalation process followed by extension of the phase.
The Chief Executive Officer of Estrella, PhD Cheng Liu, said, “The completion of the second dose cohort with a 100% CR rate states a prominent profit in our EB103 clinical program. We’re motivated by the favorable safety profile addressed in this high-risk group. Involving a CNS-related patient who specified the capability of EB103 as an effective and safe treatment for a vast cancer patient population who don’t have many options. We are planning to take EB103 to the next level of dose extension phase of STARLIGHT-1.”
Mansi Kadam is a market research writer with over 3 years of experience analyzing trends in the healthcare industry. At Towards Healthcare, she covers innovations in medical sector, sustainability initiatives, and the evolving regulatory landscape.
