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Drug

Brexucabtagene autoleucel

Approved medicine
ClassB-lymphocyte antigen CD19 binding agentResearchOngoing clinical research

Also known as Tecartus.

RxNorm2387277ChEMBLCHEMBL4594618ATCL01XL06UNII4MD2J2T8SJ
5
Active clinical trials
B-lymphocyte antigen CD19
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Trial of Nemtabrutinib in Combination With Brexu-cel for Patients With Relapsed/Refractory Mantle Cell Lymphoma

Clinical trial2026-07-01Results expected Q3 2031 · ClinicalTrials.gov

A Pilot "Window-3" Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma

Clinical trial2026-05-20Results expected Q1 2027 · ClinicalTrials.gov

A Phase 2, Open-Label, Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Clinical trial2026-03-31Results expected Q3 2029 · ClinicalTrials.gov

Phase 2 Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Clinical trial2026-03-31Results expected Q4 2028 · ClinicalTrials.gov

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

Clinical trial2026-03-25Completed · ClinicalTrials.gov

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

Clinical trial2026-03-18Results posted · ClinicalTrials.gov

Chimeric Antigen Receptor (CAR)-T Cell Therapy for Patients With Hematologic Malignancies

Clinical trial2026-01-23Results posted · ClinicalTrials.gov

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

Clinical trial2025-06-17Completed · ClinicalTrials.gov

A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies (ZUMA-25)

Clinical trial2025-01-27Terminated · ClinicalTrials.gov

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

Clinical trial2024-11-19Results posted · ClinicalTrials.gov

A Phase 1 Multicenter Study Evaluating the Safety and Tolerability of KTE-X19 in Adult Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Clinical trial2022-11-18Terminated · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Brexucabtagene autoleucel
Aliases & brands
Tecartus
RxNorm CUI
2387277
ChEMBL ID
CHEMBL4594618
ATC codes
L01XL06
UNII
4MD2J2T8SJ
Primary mechanism
B-lymphocyte antigen CD19 binding agent

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

B-lymphocyte antigen CD19
CD19 · P15391
BINDING AGENTB-lymphocyte antigen CD19 binding agent

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
3
Recruiting
4
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 11
Early Phase 11Phase 11Phase 1 / 22Phase 27

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Pediatric and Adolescent Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (ZUMA-4)

CompletedPH I/IIKite, A Gilead Companyn=952026

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

CompletedPH IIKite, A Gilead Companyn=952025

A Phase 1/2 Multi-Center Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r ALL) (ZUMA-3)

CompletedPH I/IIKite, A Gilead Companyn=1252023

A Phase 2 Multicenter Study Evaluating the Efficacy of KTE-X19 in Subjects With Relapsed/Refractory Mantle Cell Lymphoma

CompletedPH IIKite, A Gilead Companyn=1052023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials