Investing.com -- Estrella Immunopharma Inc (NASDAQ:ESLA) stock climbed 3.1% in Thursday’s premarket trading after the company announced its CD19-targeted cancer therapy received clearance to advance to Phase II clinical trials.
The clinical-stage biopharmaceutical company reported that an independent Data Safety Monitoring Board (DSMB) recommended moving its STARLIGHT-1 trial into the expansion phase following a favorable safety review of its EB103 therapy for relapsed/refractory B-cell non-Hodgkin’s lymphoma.
According to Estrella, the Phase I dose escalation portion of the trial showed no treatment-related serious adverse events across nine patients, many of whom were considered high-risk. The high-dose cohort achieved a 100% complete response rate at Month 1 in all evaluable patients.
"The advancement of EB103 into the expansion phase of STARLIGHT-1 is a pivotal milestone for Estrella," said Cheng Liu, CEO of Estrella Immunopharma. "The excellent safety profile and a 100% complete response rate observed in the high-dose cohort in Phase I demonstrated EB103’s potential to overcome the toxicity barriers that have historically restricted CD19 CAR-T use."
The company’s EB103 is a CD19-redirected ARTEMIS T-cell therapy designed to treat patients with relapsed or refractory B-cell non-Hodgkin’s lymphoma. The expansion phase will further evaluate the therapy’s safety and preliminary efficacy at the Recommended Phase II Dose.
The multi-center, open-label study includes active sites at UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute.
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