Estrella Immunopharma, Inc.
This is an open-label, multi-center, Phase 1/2 clinical trial evaluating the safety and effectiveness of EB103 in R/R B-cell NHL patients with the highest unmet medical needs, such as Human Immunodeficiency Virus (HIV)-associated lymphoma, primary and secondary central nervous system (CNS) lymphoma, and a wide range of high-grade B-cell lymphomas (HGBLs), as well as R/R large B-cell lymphoma (LBCL) patients ineligible for autologous transplant.
EB103 is an engineered T-cell therapy built on the ARTEMIS® Cell Receptor Platform. This study consists of a completed Phase 1 portion and an ongoing Phase 2 expansion portion. In Phase 1, a traditional 3+3 dose-escalation design was used to evaluate the safety and tolerability of EB103 and to determine the recommended Phase 2 dose (RP2D). Following dose escalation, an RP2D confirmatory cohort was enrolled to further characterize the safety profile of EB103 at the selected dose. Phase 2 is an expansion cohort in which additional subjects will be enrolled and treated at the RP2D to further e…
Inclusion Criteria: * Age 18 years or older at the time of informed consent * Histologically confirmed R/R B-cell non-Hodgkin's lymphoma (NHL) * Adequate organ function * Relapsed or refractory disease 1. Relapsed or refractory disease, defined as ONE OR MORE of the following modified SCHOLAR-1 criteria (Crump, 2017): * Progressive disease (PD) as best response to any line of chemoimmunotherapy * Stable disease (SD) or partial response (PR) as best response to ≥ 4 cycles of first-line chemoimmunotherapy or to ≥ 2 cycles of later-line chemoimmunotherapy * Relapse ≤ 12 months…
EB103 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the EB103 transgene.