The trial will further investigate EB103’s safety and efficacy at the recommended Phase II dose. Credit: PanuShot / Shutterstock.com.

Estrella Immunopharma has dosed the first patient in the dose-expansion segment of its STARLIGHT-1 Phase I/II trial underway, assessing EB103 for relapsed or refractory (r/r) B-cell non-Hodgkin’s lymphoma (NHL).

EB103 is a Cluster of Differentiation 19 (CD19)-redirected ARTEMIS T-cell therapy.

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The move to the dose-expansion cohort follows earlier findings from the dose-escalation stage.

In that stage, patients who achieved complete response at the Phase I six-month evaluation, and who did not have central nervous system involvement, maintained their complete response status.

The multi-centre, open-label trial is intended to further investigate the safety and efficacy of EB103 at the recommended Phase II dose in participants aged 18 years and older with r/r B-cell NHL.

Information gathered from this expansion cohort will inform the strategy for any pivotal trial involving EB103. The trial is currently recruiting at Baylor Scott & White Research Institute and UC Davis Comprehensive Cancer Center.

EB103 utilises ARTEMIS technology, licensed from Estrella’s parent company Eureka Therapeutics.

Unlike conventional CAR-T cells, ARTEMIS T-cells such as EB103 are designed to activate and regulate upon target engagement with cancer targets along mechanisms similar to endogenous T-cell receptors, aiming to bind and destroy CD19-positive cancer cells.

Estrella Immunopharma is also developing EB104, targeting both CD19 and CD22 in B-cell malignancies using the same technology.

Both therapeutic candidates are part of the company’s research in T-cell therapies for cancer and autoimmune conditions.

Estrella Immunopharma CEO Cheng Liu said: “This marks an important milestone for Estrella and STARLIGHT-1. The sustained complete responses observed to date reinforce EB103’s potential to deliver best-in-class outcomes for patients with R/R B-cell NHL. We remain deeply committed to advancing EB103.”