Tecartus (brexucabtagene autoleucel)

P1/2, N=95, Completed, Kite, A Gilead Company | Active, not recruiting --> Completed

P4, N=75, Not yet recruiting, Universitair Ziekenhuis Gent

P1, N=23, Completed, Kite Pharma Inc. | Active, not recruiting --> Completed

Brexucabtagene autoleucel (brexu-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, is a promising and available salvage option for relapsed/refractory philadelphia-positive B-Cell Acute Lymphoblastic Leukemia patients, potentially effective even after several previous lines of therapy and a previous allogeneic stem cell transplant (HSCT). This reported clinical case allowed us to highlight different relevant factors for the optimal, complex and multidisciplinary management of this subgroup of patients: bridging therapy selection, the need of reevaluating CD19 expression, disease burden as an outcome predictor and the role of HSCT as a further therapeutic consolidation.

P2, N=25, Active, not recruiting, Kite, A Gilead Company | Trial primary completion date: Jul 2027 --> Nov 2025

IEC-HS is a rare but potentially fatal complication. Our disproportionality analysis identifies significant reporting signals for tisa-cel and cilta-cel. The high absolute number of cases observed for products like axi-cel appears to reflect high utilization rather than a disproportionate risk, underscoring the necessity of using statistical signal detection methods when interpreting spontaneous reports.

This paper presents a case of a 56-year-old woman with relapsed mantle cell lymphoma (MCL) treated with the CAR-T cell therapy, brexucabtagene autoleucel, who had subsequently developed CRS and later IEC-HS. Initial management included tocilizumab, corticosteroids, and anakinra, followed by the compassionate use of emapalumab, an interferon-γ blocker...Vigilant monitoring and tailored therapeutic approaches are required to effectively manage toxicities associated with CAR-T cell therapy, to maximize its benefits and minimize adverse effects. In more severe IEC-HS cases, emapalumab may be used as an effective targeted therapy.

P2, N=95, Completed, Kite, A Gilead Company | Trial primary completion date: Nov 2024 --> Jun 2025

Brexucabtagene autoleucel (brexu-cel) is the anti-CD19 CAR-T therapy approved for the treatment of relapse/refractory (RR) mantle cell lymphoma (MCL)...Forty-nine patients received salvage therapy: 16 lenalidomide ± rituximab (Len/R2), 13 immunochemotherapy (ICT), 8 Bruton tyrosine kinase inhibitor ± venetoclax (BTKi/Ven), 7 a bispecific T-cell engager (TCE), 3 another targeted therapy, and 2 radiations...Notably, none of the TCE responders have relapsed to date (DOR of 100%). Our series highlights the poor outcomes of MCL patients following CAR-T failure and suggest a potential benefit of bispecific antibodies in this population.

P1/2, N=95, Active, not recruiting, Kite, A Gilead Company | Trial primary completion date: Sep 2024 --> Feb 2026

P1, N=8, Active, not recruiting, Stanford University | Recruiting --> Active, not recruiting | N=20 --> 8 | Trial completion date: Aug 2025 --> Jun 2027 | Trial primary completion date: Aug 2025 --> Jun 2027

P1, N=22, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting