Brexucabtagene autoleucel

Phase 2Cell therapy

Brexucabtagene autoleucel is a cell therapy that works as a CD19 CAR-T.[2] It is being investigated across 2 indications, with its most advanced program in Phase 2.[1]

Brexucabtagene autoleucel is one of 43 cell therapy programs targeting Acute Lymphoblastic Leukemia. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Acute Lymphoblastic LeukemiaCompleted

Recurrent Mantle Cell LymphomaRecruiting

Acute Lymphoblastic LeukemiaPhase 2

Completed

Recurrent Mantle Cell LymphomaPhase 2

Recruiting

Competition

Competitive Landscape

148 competitors in Acute Lymphoblastic Leukemia

#DrugCompanyPhaseTrials

Oncovin

Eli Lilly

Phase 3

73 2

Adriamycin

Pfizer

Phase 3

39 3

Oncaspar

SServier

Phase 3

47 4

Wellcovorin

EEastern Cooperative Oncology Group

Phase 3

40 5

Elspar

DDutch Childhood Oncology Group

Phase 3

44 6

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 7

Fludara

Sanofi

Phase 3

15 8

Cellcept

Roche

Phase 3

11 9

Iclusig

Neoral

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2028

Phase 2Recruiting

Recurrent Diffuse Large B-Cell Lymphoma

NCT07892027

Q3 2029

Phase 2Recruiting

Mantle Cell Lymphoma

NCT06553872

Q4 2029

Phase 2Recruiting

Non-Hodgkin Lymphoma

NCT07763210

Q3 2032

Phase 2Recruiting

Recurrent Mantle Cell Lymphoma

NCT07673367

Clinical

Trials by Indication[1]

Mantle Cell Lymphoma4 trials

Study of Brexucabtagene Autoleucel (KTE-X19) in Participants With Relapsed/Refractory Mantle Cell Lymphoma (Cohort 1 and Cohort 2)

Completed· Gilead logo

Gilead·Phase 2·NCT02601313·105 enrolled

Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Available· Gilead logo

Gilead··NCT05776134

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

Recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT06553872·60 enrolled

Show 1 more trial

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

Completed· Gilead logo

Gilead·Phase 2·NCT04880434·95 enrolled

Acute Lymphoblastic Leukemia2 trials

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

Active, not recruiting· Gilead logo

Gilead·Phase 1/2·NCT02625480·95 enrolled

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)

Completed· Gilead logo

Gilead·Phase 1/2·NCT02614066·125 enrolled

B-cell Malignancies1 trial

Study of Brexucabtagene Autoleucel in Adults With Rare B-cell Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT05537766·19 enrolled

Relapsed/Refractory B-cell Malignancies1 trial

Study of Brexucabtagene Autoleucel (KTE-X19) for the Treatment of Individuals With Relapsed/Refractory B-Cell Malignancies

Approved for marketing· Gilead logo

Gilead··NCT04162756

Chronic Lymphocytic Leukemia1 trial

Study to Evaluate the Safety and Tolerability of Brexucabtagene Autoleucel (KTE-X19) in People With Relapsed/Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma

Terminated· Gilead logo

Gilead·Phase 1·NCT03624036·16 enrolled

4 more indications

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Phase II Trial of Natalizumab for Prevention of Immune Effector Cell Associated Neurologic Syndrome (ICANS) in Patients Treated With Chimeric Antigen Receptor T-Cell Therapy for B-Cell Hematologic Malignancies

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT07892027·26 enrolled

Non-Hodgkin Lymphoma1 trial

A Phase 2 Trial of Early Enhanced Interventions to Prevent ICANS After CD19 CAR T Therapy in Patients With Non-Hodgkin Lymphoma: Lazarus Trial

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 2·NCT07763210·59 enrolled

Solid and Hematological Malignancies1 trial

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells

Enrolling by invitation· Gilead logo

Gilead··NCT05041309·1,500 enrolled

Recurrent Mantle Cell Lymphoma1 trial

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

Recruiting·VVanderbilt-Ingram Cancer Center·Phase 2·NCT07673367·25 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Brexucabtagene autoleucel. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Brexucabtagene autoleucel compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Brexucabtagene autoleucel. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 1 publication indexed for Brexucabtagene autoleucel. U.S. National Library of Medicine.
[5]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CD19 CAR-T[2]
Modality: Cell therapy[2]
Highest Phase: Phase 2[1]
Company: Gilead

Key Publications[4]

Brexu-cel in Relapsed/Refractory MCL: ZUMA-2 3-Year

BloodAug 17, 2023DOI: 10.1182/blood.2023020698

Brexucabtagene autoleucel

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q2 2028

Q3 2029

Q4 2029

Q3 2032

Trials by Indication[1]

Mantle Cell Lymphoma4 trials

Acute Lymphoblastic Leukemia2 trials

B-cell Malignancies1 trial

Relapsed/Refractory B-cell Malignancies1 trial

Chronic Lymphocytic Leukemia1 trial

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Non-Hodgkin Lymphoma1 trial

Solid and Hematological Malignancies1 trial

Recurrent Mantle Cell Lymphoma1 trial

References

Drug Info

Quick Facts

Key Publications[4]

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