Tecartus (brexucabtagene autoleucel)

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

T cell-redirecting therapies represent a central pillar in modern oncology, delivering high response rates across hematologic malignancies with expanding roles in earlier treatment settings. Future progress will depend on improving durability, optimizing sequencing, mitigating toxicity, and enhancing real-world deliverability through next-generation and multitarget platforms.

P2, N=40, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Jan 2027 --> Jul 2027 | Trial primary completion date: Jan 2027 --> Jul 2027

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.