CTL019 consists of genetically engineered autologous T cells expressing a chimeric antigen receptor (CAR).

Results from a prior single-center phase 2 study at the University of Pennsylvania showed that a single infusion of CTL019 could produce durable remissions in adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).

The JULIET trial is a Novartis-sponsored, single-arm, open-label, multicenter, global phase 2 trial of CTL019 in adult patients with r/r DLBCL.

Patients in the JULIET trial had relapse or progression after at least 2 prior lines of therapy and were not candidates for stem cell transplant.

Cryopreserved leukapheresis products were used to manufacture CAR T cells, which were provided to patients at 27 centers in 10 countries on 4 continents.

The primary endpoint was centrally reviewed best overall response rate (ORR: complete response [CR] partial response [PR]).

85 patients received a single dose of CTL019. Among 51 patients with ≥3 months follow-up or earlier discontinuation, best ORR was 59% (43% achieved CR and 16% achieved PR).

The JULIET trial met its primary endpoint.

All patients in CR at 3 months remained in CR at data cutoff.

All-grade and grade 3 or 4 cytokine release syndrome (CRS) occurred in 57% and 26% of treated patients, respectively; no CRS-related deaths were reported.

21% and 13% of patients had all-grade and grade 3 or 4 neurologic events, respectively; no cases of cerebral edema were reported.

No deaths were attributed to CTL019.

This preplanned interim analysis of a global study of CTL019 in adults with r/r DLBCL is consistent with the high response rates and durable responses observed in the previous single-center experience.

Source: EHA