Brexucabtagene Autoleucel
drugOn this page
Also known as KTE-X19Tecartus
Summary
Brexucabtagene Autoleucel (CHEMBL4594618) is an approved gene (ATC L01XL06); indicated across 6 conditions including mantle cell lymphoma and acute lymphoblastic leukemia.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Gene
- ATC class: L01XL06
- Indications: 6 conditions
- Clinical trials: 15
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL4594618 |
| Name | Brexucabtagene Autoleucel |
| Type | Gene |
| Max phase | 4 |
| ATC | L01XL06 |
Also known as: Brexucabtagene autoleucel, KTE-X19, Tecartus, BREXUCABTAGENE AUTOLEUCEL
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
6 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| mantle cell lymphoma | 4 | MONDO:0018876 | EFO:1001469 |
| acute lymphoblastic leukemia | 2 | MONDO:0004967 | EFO:0000220 |
| lymphoid neoplasm | 2 | MONDO:0005157 | EFO:0001642 |
| lymphoid leukemia | 2 | MONDO:0005402 | EFO:0004289 |
| B-cell chronic lymphocytic leukemia | 1 | MONDO:0004948 | EFO:0000095 |
| neoplasm | 1 | MONDO:0005070 | EFO:0000616 |
Clinical trials
Total trials: 15.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 8 |
| Not specified | 3 |
| PHASE1/PHASE2 | 2 |
| PHASE1 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT03642626 | PHASE2 | ACTIVE_NOT_RECRUITING | MT2017-45: CAR-T Cell Therapy for Heme Malignancies |
| NCT06144606 | PHASE2 | RECRUITING | Study of KTE-X19 in Minimal Residual Disease (MRD) Positive B-Cell Acute Lymphoblastic Leukemia (B-ALL) |
| NCT06253663 | PHASE2 | ACTIVE_NOT_RECRUITING | Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia |
| NCT06482684 | PHASE2 | RECRUITING | CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma |
| NCT06553872 | PHASE2 | RECRUITING | Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL |
| NCT02601313 | PHASE2 | COMPLETED | Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2) |
| NCT02614066 | PHASE1/PHASE2 | COMPLETED | A Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel (KTE-X19) in Adult Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ZUMA-3) |
| NCT02625480 | PHASE1/PHASE2 | COMPLETED | Study Evaluating Brexucabtagene Autoleucel (KTE-X19) in Pediatric and Adolescent Participants With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma |
| NCT04880434 | PHASE2 | COMPLETED | Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 3) |
| NCT05537766 | PHASE2 | TERMINATED | Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies |
| NCT03624036 | PHASE1 | TERMINATED | Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| NCT05495464 | EARLY_PHASE1 | ACTIVE_NOT_RECRUITING | A Pilot Window-3 Study of Acalabrutinib Plus Rituximab Followed by Brexucabtagene Autoleucel Therapy in Patients With Previously Untreated High-risk Mantle Cell Lymphoma |
| NCT05041309 | Not specified | ENROLLING_BY_INVITATION | Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells |
| NCT05776134 | Not specified | AVAILABLE | Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel |
| NCT04162756 | Not specified | APPROVED_FOR_MARKETING | Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: mantle cell lymphoma