Dec. 4 at 2:58 PM
Estrella Immunopharma said its CD19-targeted cancer therapy received clearance to advance into Phase II testing. An independent safety board recommended moving its STARLIGHT-1 trial into an expansion phase after a favorable safety review of EB103 for relapsed or refractory B-cell non-Hodgkin lymphoma.
The Phase I dose-escalation stage showed no treatment-related serious adverse events in nine patients, many considered high risk, and the high-dose cohort achieved a 100% complete response rate at Month 1.
Estrella called this a major milestone, noting EB103’s strong safety profile and full responses suggest it may overcome toxicity challenges that have historically limited CD19-targeted CAR-T therapies. The expansion phase will further evaluate safety and early efficacy at the recommended Phase II dose.
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