Posted: Friday, July 22, 2022
An ongoing phase Ib trial, the details of which were presented at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (Abstract TPS7596), seeks to determine the safety and efficacy of efineptakin alfa (NT-17), a long-acting human interleukin (IL)-7, in some patients with large B-cell lymphoma (LBCL) after therapy with the chimeric antigen receptor (CAR) T-cell therapy tisagenlecleucel. Previous studies have demonstrated an association between NT-17 therapy and increased CAR T cells.
“We hypothesize that NT-I7 administration after tisagenlecleucel [standard of care] for subjects with [relapsed/refractory] LBCL may increase expansion and persistence of CAR-T, leading to increased tumor response rate and improved clinical outcomes without safety concerns,” noted Armin Ghobadi, MD, of the Washington University School of Medicine, St. Louis, and colleagues.
Eligible patients include those who have received at least two prior lines of therapy and have a biopsy-proven diagnosis. A maximum of 42 enrolled patients will first undergo dose escalation, receiving a tisagenlecleucel infusion on day 0 and a dose of NT-17 on day 21 at one of the following dose levels: 60, 120, 240, 360, 480, 600, or 720 μg/kg (dose levels 1–7, respectively). Dose levels 1 and 2 will be administered to one patient each, whereas the remaining dose levels will be administered following a 3 + 3 scheme. A recommended phase II dose will be determined. Following the dose-escalation phase, a maximum of 15 patients will be enrolled in the dose-expansion phase, in which they will receive the recommended phase II dose. As of January 2022, two patients had entered the dose-escalation phase.
The primary endpoints are evaluation of safety and tolerability as well as determination of the maximum recommended dose. Secondary endpoints include evaluation of antitumor activity and the safety implications of NT-17 administration after therapy with tisagenlecleucel. Exploratory objectives include identification of the pharmacokinetic boundaries of combination tisagenlecleucel plus NT-17.
Disclosure: For full disclosures of the study authors, visit coi.asco.org.