NCT04162756: ZUMA-18

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

APPROVED FOR MARKETING Last updated 14 October 2021

What this trial tests

trial testing Brexucabtagene Autoleucel (KTE-X19) in Relapse/Refractory Mantle Cell Lymphoma. Approved for marketing.

Quick facts

Lead sponsor	Kite, A Gilead Company
Status	APPROVED FOR MARKETING
Study type	EXPANDED_ACCESS
Sites	9 locations across United States

Drugs / interventions tested

• Brexucabtagene Autoleucel (KTE-X19) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Relapse/Refractory Mantle Cell Lymphoma — all drugs for Relapse/Refractory Mantle Cell Lymphoma →

Sponsor

Kite, A Gilead Company — full company profile →

Who can join

18 and older, any sex, with Relapse/Refractory Mantle Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The primary objectives of this study are:

Cohort 1: to provide access to brexucabtagene autoleucel (KTE-X19) for individuals with relapsed or refractory (r/r) mantle cell lymphoma (MCL) until KTE-X19 is commercially available

Cohort 2: To provide access to KTE-X19 for individuals with r/r MCL whose commercially manufactured product did not meet commercial release specification(s)

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. CAR-T cell therapy for cancer: current challenges and future directions.
   Zugasti I, Espinosa-Aroca L, Fidyt K, Mulens-Arias V, et al · · 2025 · cited 81× · PMID 40610404 · DOI 10.1038/s41392-025-02269-w
2. CAR T-Cell Therapy for B-Cell non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Clinical Trials and Real-World Experiences.
   Vitale C, Strati P. · · 2020 · cited 63× · PMID 32670869 · DOI 10.3389/fonc.2020.00849
3. A Deep Insight Into CAR-T Cell Therapy in Non-Hodgkin Lymphoma: Application, Opportunities, and Future Directions.
   Marofi F, Rahman HS, Achmad MH, Sergeevna KN, et al · · 2021 · cited 37× · PMID 34248965 · DOI 10.3389/fimmu.2021.681984
4. CAR T-Cell therapy for the management of mantle cell lymphoma.
   Huang Z, Chavda VP, Bezbaruah R, Dhamne H, et al · · 2023 · cited 35× · PMID 37004047 · DOI 10.1186/s12943-023-01755-5
5. Chimeric Antigen Receptor (CAR) T-Cell Therapy in Hematologic Malignancies: Clinical Implications and Limitations.
   Blüm P, Kayser S. · · 2024 · cited 22× · PMID 38672680 · DOI 10.3390/cancers16081599
6. Development and clinical translation of <i>ex vivo</i> gene therapy.
   Wu X, He X, Liu F, Jiang X, et al · · 2022 · cited 15× · PMID 35782737 · DOI 10.1016/j.csbj.2022.06.015
7. T-Cell-Redirecting Immunotherapies in Relapsed/Refractory Mantle Cell Lymphoma: Current Evidence, Sequencing, and Future Directions.
   Caserta S, Martino EA, Vigna E, Bruzzese A, et al · · 2026 · cited 1× · PMID 41207679 · DOI 10.1111/ejh.70063