First Patient Treated in Second Cohort of STARLIGHT-1 B-Cell NHL Trial

The phase 1/2 STARLIGHT-1 trial has dosed the first patient in the second cohort of the dose escalation study which is evaluating the CD19-redirected Artemis T-cell therapy, EB103, for the treatment of patients with advanced B-cell non-Hodgkin lymphomas (NHL), according to a news release from Estrella Immunopharma, Inc.

“We are excited to announce another important milestone in our STARLIGHT-1 trial and are encouraged by the favorable safety profile and the complete response observed in the first cohort,” said Cheng Liu, CEO of Estrella. “EB103 has a significant potential to address key limitations of traditional CAR-T therapies by mitigating safety risks and expanding accessibility to high-risk patient groups, including those with HIV-associated lymphoma and central nervous system (CNS) lymphoma — conditions that are excluded from existing CAR-T options. We look forward to evaluating EB103 at higher doses and delivering the treatments to patients soon.”

EB103 is being evaluated at a higher dose level in the second cohort of the study, the news release continues. This decision follows a safety review of data from the first dose cohort, as no dose-limiting toxicities were reported. Moreover, there were no treatment-related side effects observed in the first cohort of patients.

“The initiation of dosing in the second cohort reflects steady progress in Estrella’s mission to complete phase 1 of STARLIGHT-1," the company emphasized in the news release.

More Information on Treatment With EB103

EB103 is a T-cell therapy, also known as the CD19-Redirected Artemis T-Cell Therapy, which is based on Artemis technology licensed from Estrella Immunopharma’s parent company, Eureka Therapeutics, Inc. Unlike conventional CAR-T cells, Artemis T cells such as EB103 are designed to be activated and regulated after being engaged with cancer targets, closely mimicking the natural function of endogenous T cell receptors.

Following infusion, EB103 T cells target and bind to CD19-expressing cancer cells, leading to their destruction.

Breaking Down the Phase 1/2 STARLIGHT-1 Trial

The phase 1/2 STARLIGHT-1 trial is an open-label, dose escalation, multi-center study which is evaluating the safety, and determining a recommended phase 2 dose of EB103 in adult patients with relapsed/refractory B-cell NHL. The study also includes a dose escalation phase, as well as an expansion phase, according to the trial information listed on clinicaltrials.gov.

Eligible participants must be 18 years or older with histologically confirmed relapsed or refractory B-cell NHL. Participants must have adequate organ function and have experienced disease progression under specific conditions. These include progression after two or more prior lines of systemic therapy or, for patients with Burkitt lymphoma, precursor B-cell lymphoblastic lymphoma or mantle cell lymphoma, after one or more lines.

Additional qualifying factors include recurrence within 12 months following autologous hematopoietic stem cell transplantation (HSCT), or, in transplant-ineligible individuals and progression on defined first- and second-line therapies, the clinicaltrials.gov webpage continued.

Exclusion criteria include prior exposure to CD19-targeted cellular therapies or a history of Richter transformation of chronic lymphocytic leukemia. Individuals with unresolved primary malignancies, active or progressing central nervous system involvement or cardiac lymphoma unresponsive to treatment are ineligible. Other disqualifying conditions include significant recent cardiac events, uncontrolled infections, autoimmune diseases causing end-organ damage or requiring immunosuppressants within the past 2 years and hypersensitivity to study agents.

Eligible patients will be enrolled onto the study, where a traditional dose escalation model will be used to determine the recommended phase 2 dose of EB103. Once a dose has been decided, the expansion phase will be underway. Moreover, additional participants will be enrolled in the expansion portion of the study to further confirm the safety profile of EB103 as well as evaluate the preliminary efficacy of the agent.

The phase 1/2 STARLIGHT-1 trial is currently recruiting participants, according to Estrella Immunopharma’s website.

The study has one location, according to clinicaltrials.gov, which is in Sacramento, California, at the University of California, Davis, UC Davis Comprehensive Cancer Center.

For more information regarding the phase 1/2 STARLIGHT-1 trial, please visit www.clinicaltrials.gov using the identifier: NCT06343311.

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