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Brexucabtagene Autoleucel · Tecartus

Cell therapy (CAR-T) · Kills target cells, directed at CD19 · developed by Kite Pharma

Approved FDA, Jul 2020

GILD Developer

1 Registered trials

What is Brexucabtagene Autoleucel?

Tecartus is a CD19-directed autologous CAR T cell therapy engineered with CD28 and CD3-zeta co-stimulatory domains. Upon engagement with CD19-expressing cancer cells, it activates T cell proliferation and effector functions, leading to killing of CD19-expressing cells.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Tecartus
Drug type: Cell therapy (CAR-T)
Targets: CD19 (antigen)
Mechanism: Kills target cells, directed at CD19
Pathways: T cell activation, cytokine secretion
Therapy area: Oncology
Developer: Kite Pharma, Inc. (GILD)
FDA status: Approved as Tecartus (July 24, 2020), BLA125703 · FDA label
UNII: 4MD2J2T8SJ

✅ FDA-approved uses

Relapsed or refractory mantle cell lymphoma
Relapsed or refractory B-cell precursor acute lymphoblastic leukemia

From the indications section of the FDA label (version of Jun 16, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT07763210	Phase 2	Non-hodgkin Lymphoma	Recruiting	GILD

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Non-hodgkin LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Mantle Cell LymphomaRefractory Mantle Cell LymphomaRefractory Marginal Zone Lymphoma

Other drugs acting on CD19

Blinatumomab FDA approved Inebilizumab FDA approved Loncastuximab tesirine FDA approved Budoprutug Phase 1/2 MK-1045 Phase 2/3

More from Kite Pharma

Axicabtagene Ciloleucel FDA approved Bictegravir FDA approved Bulevirtide FDA approved Cobicistat FDA approved Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDA approved Emtricitabine And Tenofovir Alafenamide FDA approved Emtricitabine/Tenofovir Disoproxil FDA approved Lenacapavir FDA approved Remdesivir FDA approved Sacituzumab Govitecan FDA approved Seladelpar FDA approved Tenofovir Disoproxil FDA approved

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the GILD page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z