Estrella Immunopharma advances the STARLIGHT-1 trial to Phase II based on positive safety data for EB103, a CD19-redirected ARTEMIS® T-cell therapy.
DSMB confirms EB103's favorable safety profile with no serious adverse events, even in high-risk patients ineligible for current CD19 products.
High-dose cohort in Phase I achieved a 100% complete response rate at Month 1, supporting EB103 as a potential best-in-class CD19 CAR-T therapy.
DSMB Recommendation
Independent DSMB recommends advancing STARLIGHT-1 to Phase II at Recommended Phase II Dose (RP2D) based on favorable safety profile.
High-Dose Cohort Response
High-dose cohort in Phase I achieved a 100% complete response rate at Month 1, demonstrating potential efficacy of EB103.
Commercial Reach Expansion
EB103 shows potential to expand commercial reach of cell therapy, delivering a best-in-class solution to a broader NHL population.
- Advancement to Phase II indicates positive safety and efficacy data for EB103 in treating R/R B-cell non-Hodgkin's lymphoma.
- 100% complete response rate in high-dose cohort highlights the potential efficacy of EB103 as a CD19 CAR-T therapy.
- Expansion phase aims to further evaluate EB103's safety and efficacy at RP2D, shaping pivotal trial strategy.
Estrella's advancement of EB103 into the expansion phase of STARLIGHT-1 marks a pivotal milestone in overcoming barriers in CD19 CAR-T therapy, potentially offering a best-in-class solution for a broader NHL population.