Evidence map›Paper›PMID 42036693›Full record

ArticleJournal of hematology & oncology2026

Five-year follow-up of patients with relapsed/refractory mantle cell lymphoma treated with anti-CD19 CAR T-cell therapy in ZUMA-2, Cohorts 1 and 2.

Javier Muñoz, Frederick L Locke, Patrick M Reagan, Andre Goy, Caron A Jacobson, Brian T Hill, John M Timmerman, Ian W Flinn, David B Miklos, John M Pagel and 12 more

3 registry-linked trialsAbstract readMulticenter Study
In one paragraph

Article in Journal of hematology & oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02601313 phase2completednot on this map

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

TypeinterventionalSponsorKite, A Gilead CompanyRan2015 to 2023Enrolled105ConditionsRelapsed/Refractory Mantle Cell LymphomaArmsbrexucabtagene autoleucel, Cyclophosphamide, Fludarabine, Axicabtagene Ciloleucel
NCT04880434 phase2completednot on this map

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

TypeinterventionalSponsorKite, A Gilead CompanyRan2021 to 2025Enrolled95ConditionsRelapsed/Refractory Mantle Cell LymphomaArmsFludarabine, Cyclophosphamide, Brexucabtagene autoleucel
NCT05041309 enrolling by invitationnot on this map

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

TypeobservationalSponsorKite, A Gilead CompanyRan2021 to 2040Enrolled1,000ConditionsSolid and Hematological MalignanciesArmsAxicabtagene Ciloleucel, Brexucabtagene Autoleucel, Anitocabtagene autleucel, KITE-753, KITE-197
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

22 authors.

Javier Muñoz *Banner MD Anderson Cancer Center, Gilbert, AZ, USA.
Frederick L Locke *Moffitt Cancer Center, Tampa, FL, USA.
Patrick M ReaganUniversity of Rochester School of Medicine, Rochester, NY, USA.
Andre GoyJohn Theurer Cancer Center, Hackensack, NJ, USA.
Caron A JacobsonDana-Farber Cancer Institute, Boston, MA, USA.
Brian T HillCleveland Clinic Foundation, Cleveland, OH, USA.
John M TimmermanUCLA David Geffen School of Medicine, Los Angeles, CA, USA.
Ian W FlinnTennessee Oncology & One Oncology, Nashville, TN, USA.
David B MiklosStanford University, Stanford, CA, USA.
John M PagelSwedish Cancer Institute, Seattle, WA, USA.
Marie José KerstenAmsterdam UMC, University of Amsterdam Cancer Center, Amsterdam, Netherlands.
Edouard ForcadeService d'Hématologie Clinique et Thérapie Cellulaire, CHU Bordeaux, Pessac, France.
Max S ToppMedizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany.
Roch HouotCHU Rennes, Université Rennes, Inserm & EFS, Rennes, France.
Amer BeitinjanehUniversity of Miami, Miami, FL, USA.
Dan ZhengKite, a Gilead Company, Santa Monica, CA, USA.
Mengru ChangKite, a Gilead Company, Santa Monica, CA, USA.
Wangshu ZhangKite, a Gilead Company, Santa Monica, CA, USA.
Rhine R ShenKite, a Gilead Company, Santa Monica, CA, USA.
Rita Damico KhalidKite, a Gilead Company, Santa Monica, CA, USA.
Ioana KloosKite, a Gilead Company, Santa Monica, CA, USA.
Michael L WangThe University of Texas MD Anderson Cancer Center, Houston, TX, USA. miwang@mdanderson.org.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment with brexucabtagene autoleucel (brexu-cel), an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, demonstrated a high objective response rate (93%) and complete response rate (67%) in 60 patients with relapsed/refractory mantle cell lymphoma (R/R MCL) treated in the pivotal ZUMA-2 Cohort 1 study. Subsequently, brexu-cel was approved in the United States and European Union for the treatment of adults with R/R MCL (after ≥ 2 prior therapies in the European Union). Here we report 5-year outcomes from the pivotal ZUMA-2 Cohort 1 study (N = 68), as well as two previously unpublished ZUMA-2 data sets, long-term outcomes in 10 patients who received axi-cel in Cohort 1 and in 14 patients who received a lower dose of brexu-cel in Cohort 2.

methodsThe primary endpoint for all cohorts of ZUMA-2 was objective response rate. Key secondary endpoints included duration of response (DOR), overall survival (OS), and safety. Patients could transition to a long-term follow-up study after 24 months for monitoring of survival and select adverse events possibly related to brexu-cel. Patients in Cohort 1 received a single infusion of 2 × 10

resultsMedian follow-up for the pivotal cohort (N = 68) was 67.8 months (range, 58.2-88.6) with a median DOR of 36.5 months (n = 60), per investigator review. Median OS was 46.5 months (95% CI, 24.5-60.2; N = 68) and was 60.2 months (95% CI, 42.8-not estimable) in patients with complete response (n = 46). The 5-year incidence of cumulative relapse-related and non-relapse-related mortality was 40% (24/60) and 22% (13/60) in responders, respectively. Descriptive outcomes for axi-cel-treated patients (N = 10) and Cohort 2 (N = 14) are reported herein. No Grade 5 cytokine-release syndrome or neurologic events, subsequent T-cell malignancies, or new safety signals were reported in any patient.

conclusionsPatients in ZUMA-2 continued to have durable responses after 5 years of follow-up with predictable long-term safety, supporting the continued use of brexu-cel in R/R MCL. Interpretations of outcomes in axi-cel-treated patients and Cohort 2 are not feasible due to small patient numbers and unmatched baseline characteristics.

trial registrationNCT02601313 and NCT05041309.

Indexed as

Antigens, CD19Immunotherapy, AdoptiveLymphoma, Mantle-CellReceptors, Chimeric AntigenAdultAgedCohort StudiesFemaleFollow-Up StudiesHumansMaleMiddle AgedNeoplasm Recurrence, LocalRecurrenceTreatment OutcomeAntigens, CD19Receptors, Chimeric AntigenBrexu-celCAR T-cell therapyLong-term follow-upMantle cell lymphomaZUMA-2

Identifiers

PMID42036693
PMCPMC13242663

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.