CHICAGO—A novel CD19-targeted T-cell therapy induced complete metabolic responses (CMRs) and no cytokine release syndrome (CRS) in patients with B-cell lymphomas in a first-in-human clinical study.
All subjects achieving CMR at the 1-month safety and efficacy assessment continued to show CMR at 3 months, investigators reported at the 2018 ASCO Annual Meeting (abstract 3049*).
The therapy is built on a novel platform, ARTEMIS, designed to match the potency of chimeric antigen receptor (CAR) T-cell therapy but trigger less cytokine release when the target is engaged, investigators explained.
That platform is “potentially a major improvement” over existing CAR-T cell therapy, said Zhi Tao Ying, MD, of Peking University Cancer Hospital & Institute in Beijing, China, and coauthors in a poster presented at ASCO.
The treatment, called ET190L1-ARTEMIS, utilizes the T-cell receptor platform and a proprietary human anti-CD19 antibody to target CD19-positive malignancies.
The investigators reported on 21 adults with CD-19 positive relapsed and refractory B-cell lymphomas who had received a median of 4 lines of previous therapy.
Patients received autologous ET190L1-ARTEMIS T cells in 1 of 3 dosing cohorts: 3 patients at 1 x 106/kg, 13 at 3 x 106/kg, and 5 at 6 x 106/kg.
Of 17 patients completing a first-month efficacy assessment, 11 (65%) responded, including 7 CMRs and 3 partial responses. One patient had stable disease.
Seven of the 11 responders completed a third-month efficacy assessment, as of this analysis. Of 5 patients with CMR at month 1, all 5 maintained CMR at month 3. Likewise, 1 patient in partial response and 1 with stable disease at month 1 had the same response status at month 3.
There were no cases of CRS or neurotoxicity in 17 patients who completed the 1-month safety and efficacy assessment reported at ASCO. Grade 3 or greater adverse events in those subjects included lymphopenia in 17 (100%) and neutropenia in 5 (29%).
Eureka Therapeutics Inc., of Emeryville, California, is developing ET190L1-ARTEMIS. Co-investigators in this trial were from Eureka, Xi-An Jiaotong University in China, and Duke University School of Medicine in Durham, North Carolina.
A phase 1 trial of ET190L1-ARTEMIS in patients with relapsed and refractory non-Hodgkin lymphoma has been initiated at Duke University, and investigators say another US phase 1 trial including relapsed and refractory pediatric acute lymphoblastic leukemia patients will begin later this year.
Data in the abstract differ from that presented in the poster.