First Patient Dosed Achieves Complete Response in Estrella Immunopharma’s Trial for CD19-Targeted T-cell Therapy EB103 in B-Cell Lymphomas
Estrella noted that the patient had been diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms.
The first patient dosed in Estrella Immunopharma’s phase 1/2 STARLIGHT-1 clinical trial (NCT06343311) evaluating EB103, an investigational autologous CD19-targeted T-cell therapy, for the treatment of B-cell lymphomas has achieved a complete response (CR).1
Estrella noted that the patient had been diagnosed with follicular lymphoma grade 3A with high-risk 3B symptoms and that their disease had relapsed 3 times after previous treatments. Treatment with EB103 took place at UC Davis Comprehensive Cancer Center. Estrella pointed out that the patient’s disease was considered high-risk because of high tumor burden and multiple comorbidities—factors that might increase the severity of adverse events (AEs) like cytokine release syndrome (CRS) and neurotoxicity in patients being treated with commercially available CAR-T therapy options. Although, the patient did not experience any treatment-related serious AEs following administration of EB103.
EB103 is based on a technology referred to as ARTEMIS, which was developed by Estella’s parent company Eureka Therapeutics and differs from traditional CAR-T technology in that it allows the T-cells to be activated via a pathway more similar to that seen in endogenous T-cell receptors.2,3 Notably, ARTEMIS T-cells are able to target intracellular cancer-specific antigens in addition to the surface-antigens typically used as targets for CAR-T.4
“We are cautiously optimistic about these early results and the favorable safety profile of EB103 observed in our first treated patient of this clinical trial,” Cheng Liu, PhD, president and chief executive officer at Estrella, said in a statement.1 “Our goal is to develop ARTEMIS® T-cell therapies that not only match but also surpass the efficacy of commercially available CAR-T therapies, while also addressing their safety shortcomings. By improving safety, we hope to reach a broader patient population and make T-cell therapy accessible in community hospitals, not just specialized cancer centers.”
Estrella originally announced that the first patient in the study had been dosed in July 2024.2 The investigational new drug application enabling the trial’s initiation was cleared by the FDA in March 2023.5 Notably, the IND allows for inclusion of patients with HIV-associated lymphoma and primary and secondary central nervous system lymphoma.
"CAR-T therapies have improved outcomes for patients with B-cell nonHodgkin lymphomas (NHLs) compared with traditional standard-of-care treatments,” Mehrdad Abedi, MD, a professor of medicine at UC Davis Comprehensive Cancer Center, said in a July 2024 statement.2 “However, patients battling relapsed/refractory (r/r) NHL, especially those with high-risk conditions such as HIV-associated lymphoma, central nervous system lymphoma, and additional high-grade NHL subtypes urgently need new therapeutic options that minimize the risk of potential life-threatening side effects, including severe CRS and neurotoxicity. EB103 ARTEMIS T-cell therapy represents an innovative treatment option that may potentially benefit a wider range of r/r B-cell NHL patients.”
The open-label, multicenter trial takes the form of a dose escalation and expansion study.1 It is open to patients aged 18 years an older with histologically confirmed r/r B-cell NHL. According to the clinicaltrials.gov page, which was most recently updated on August 2, 2024, UC Davis Comprehensive Cancer Center is the only location currently recruiting patients. Naseem Esteghamat, MD, an assistant professor of medicine at UC Davis Comprehensive Cancer Center, is serving as the principal investigator for the study.
“We are excited to see the positive early safety and efficacy results in our first treated patient,” Esteghamat added to Liu’s statement.1 “We look forward to continuing our study to further validate these findings and expand access to this potentially curative therapy.”
