Estrella Immunopharma Doses First Patient in STARLIGHT-1 Dose-Expansion Phase for EB103 ARTEMIS T-Cell Therapy in R/R B-Cell NHL
核心洞察
Estrella Immunopharma (搜索) has dosed the first patient in the dose-expansion phase of the phase 1/2 STARLIGHT-1 trial evaluating EB103, a CD19 (搜索)-redirected ARTEMIS T-cell therapy, in relapsed/refractory B-cell non-Hodgkin lymphoma (搜索).
All evaluable patients without CNS involvement who achieved a complete response in the dose-escalation phase remained in CR at the 6-month assessment, demonstrating durable responses.
No treatment-related serious adverse events were reported among 9 patients treated in the dose-escalation phase, including high-risk patients ineligible for commercially available CD19 (搜索)-directed cell therapies.
Estrella Immunopharma (搜索) has dosed the first patient in the dose-expansion phase of its ongoing STARLIGHT-1 phase 1/2 clinical trial (NCT06343311), evaluating EB103 — a CD19 (搜索)-redirected ARTEMIS T-cell therapy — in adults with relapsed/refractory (R/R) B-cell non-Hodgkin lymphoma (搜索) (NHL). The milestone follows encouraging safety and efficacy data from the dose-escalation portion of the study, including durable complete responses and a clean safety profile that prompted an independent data safety monitoring board (DSMB) to recommend advancing to the expansion phase.
"We remain deeply committed to advancing EB103," said Cheng Liu, PhD, Chief Executive Officer of Estrella. "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."
Durable Responses and Clean Safety Profile from Dose Escalation
Among evaluable patients from the phase 1 dose-escalation portion of STARLIGHT-1 without central nervous system (CNS) involvement, all patients who achieved a complete response (CR) remained in CR at the 6-month assessment. Earlier, in the second dose-escalation cohort, all evaluable patients achieved a CR at the month 1 assessment — a group that included one patient with CNS lymphoma.
As of the December 2025 DSMB review, no treatment-related serious adverse events (AEs) had been reported among 9 patients treated in the dose-escalation phase. Notably, this cohort included high-risk patients who were not eligible to receive commercially available CD19 (搜索)-directed cell therapies. Based on this safety profile, the DSMB recommended proceeding to the expansion phase at the recommended phase 2 dose (RP2D).
How EB103 Differs from Conventional CAR T-Cell Therapy
EB103 utilizes ARTEMIS technology, licensed from Eureka Therapeutics (搜索), Estrella's parent company. Unlike a conventional chimeric antigen receptor (CAR) T-cell construct, an ARTEMIS T-cell is designed to be activated and regulated through a cellular mechanism that more closely resembles that of an endogenous T-cell receptor once it engages a cancer target. EB103 targets CD19 (搜索), a protein expressed on the surface of nearly all B-cell leukemias and lymphomas. Estrella is also developing EB104, a second ARTEMIS-based T-cell therapy designed to target both CD19 and CD22 (搜索).
STARLIGHT-1 Trial Design and Next Steps
The expansion phase is designed as a multicenter, open-label study intended to further evaluate the safety and efficacy of EB103 at the RP2D in patients 18 years and older with R/R B-cell NHL. Current active sites include UC Davis Comprehensive Cancer Center and Baylor Scott & White Research Institute. Data from this cohort will be used to determine the pivotal trial strategy for EB103.
STARLIGHT-1 began enrolling in June 2024, with an estimated primary completion date of December 2026. The primary endpoints of the trial include the incidence of dose-limiting toxicities and treatment-emergent AEs, as well as determining the RP2D in the phase 1 portion. Secondary endpoints include overall response rate, disease control rate, duration of response, progression-free survival, event-free survival, overall survival, and pharmacokinetics.
Addressing Unmet Need in CD19-Directed Cell Therapy
Several CD19 (搜索)-directed CAR T-cell therapies are already commercially available for relapsed/refractory B-cell NHL, but not all patients are eligible for them — including some with CNS involvement or other high-risk disease features. The early safety and efficacy signals from STARLIGHT-1 suggest EB103 may offer a therapeutic option for these underserved patient populations, though further data from the expansion phase will be needed to confirm this potential.