Evidence map›Paper›PMID 33827116›Full record

ArticleBlood2021

KTE-X19 anti-CD19 CAR T-cell therapy in adult relapsed/refractory acute lymphoblastic leukemia: ZUMA-3 phase 1 results.

Bijal D Shah, Michael R Bishop, Olalekan O Oluwole, Aaron C Logan, Maria R Baer, William B Donnellan, Kristen M O'Dwyer, Houston Holmes, Martha L Arellano, Armin Ghobadi and 17 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Blood, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02614066 (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), which is not on this map. Cited by 127 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
127citing papers in PubMed, 5 pooled it
14.6field-weighted citation impact, top 1% of its field
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.

NCT02614066 phase1 / phase2completednot on this map

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)

TypeinterventionalSponsorKite, A Gilead CompanyRan2016 to 2023Enrolled125ConditionsRelapsed/Refractory B-precursor Acute Lymphoblastic LeukemiaArmsbrexucabtagene autoleucel, Cyclophosphamide, Fludarabine
3 · Its place in the literature

Who cites it

127 citing papers in PubMed, 5 syntheses or guidelines pooled it, 192 citations in OpenAlex.

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67 more citing papers are in PubMed but not listed here.

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

27 authors at 20 institutions in 1 country.

Bijal D ShahDivision of Hematology/Oncology, Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL.
Michael R BishopDivision of Hematology/Oncology, The University of Chicago Medicine, Chicago, IL.
Olalekan O OluwoleDivision of Hematology/Oncology, Vanderbilt-Ingram Cancer Center, Vanderbilt University School of Medicine, Nashville, TN.ORCID 0000-0001-8525-9641
Aaron C LoganDivision of Hematology/Oncology, Helen Diller Comprehensive Cancer Center, University of California San Francisco, San Francisco, CA.ORCID 0000-0002-1179-5879
Maria R BaerMarlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore, MD.
William B DonnellanSarah Cannon Research Institute, Nashville, TN.
Kristen M O'DwyerAcute Leukemia Program, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY.
Houston HolmesTexas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, TX.
Martha L ArellanoDivision of Hematology/Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
Armin GhobadiSection of Stem Cell Transplant and Leukemia, Division of Medical Oncology, Washington University School of Medicine-Siteman Cancer Center, St Louis, MO.
John M PagelCenter for Blood Disorders and Stem Cell Transplantation, Swedish Cancer Institute, Seattle, WA.
Yi LinDivision of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Ryan D CassadayDivision of Hematology and Clinical Research, University of Washington School of Medicine-Fred Hutchinson Cancer Research Center, Seattle, WA.ORCID 0000-0002-3424-2425
Jae H ParkDivision of Hematologic Malignancies, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.
Mehrdad AbediDepartment of Internal Medicine, University of California Davis Medical Center, Sacramento, CA.
Januario E CastroDivision of Hematology-Oncology, Mayo Clinic, Phoenix, AZ.ORCID 0000-0003-2785-0892
Daniel J DeAngeloDivision of Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA.
Adriana K MaloneDivision of Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, NY.ORCID 0000-0003-1581-3445
Raya MawadCenter for Blood Disorders and Stem Cell Transplantation, Swedish Medical Center, Seattle, WA.
Gary J SchillerDivision of Hematology/Oncology, Department of Medicine, David Geffen School of Medicine, University of California at Los Angeles, Los Angeles, CA.
John M RossiKite, a Gilead Company, Santa Monica, CA; and.
Adrian BotKite, a Gilead Company, Santa Monica, CA; and.
Tong ShenKite, a Gilead Company, Santa Monica, CA; and.
Lovely GoyalKite, a Gilead Company, Santa Monica, CA; and.
Rajul K JainKite, a Gilead Company, Santa Monica, CA; and.
Remus VezanKite, a Gilead Company, Santa Monica, CA; and.
William G WierdaDivision of Cancer Medicine, Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX.
Dana-Farber Cancer Institute · USEmory University · USIcahn School of Medicine at Mount Sinai · USMayo Clinic Hospital · USMayo Clinic in Arizona · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USSarah Cannon · USSwedish Medical Center · USSwedish Medical Center · USTexas Oncology · USThe University of Texas MD Anderson Cancer Center · USUniversity of California Davis Medical Center · USUniversity of California, Los Angeles · USUniversity of California, San Francisco · USUniversity of Chicago · USUniversity of Maryland, Baltimore · USUniversity of Rochester Medical Center · USUniversity of Washington · USVanderbilt University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

ZUMA-3 is a phase 1/2 study evaluating KTE-X19, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in adult relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). We report the phase 1 results. After fludarabine-cyclophosphamide lymphodepletion, patients received a single infusion of KTE-X19 at 2 × 106, 1 × 106, or 0.5 × 106 cells per kg. The rate of dose-limiting toxicities (DLTs) within 28 days after KTE-X19 infusion was the primary end point. KTE-X19 was manufactured for 54 enrolled patients and administered to 45 (median age, 46 years; range, 18-77 years). No DLTs occurred in the DLT-evaluable cohort. Grade ≥3 cytokine release syndrome (CRS) and neurologic events (NEs) occurred in 31% and 38% of patients, respectively. To optimize the risk-benefit ratio, revised adverse event (AE) management for CRS and NEs (earlier steroid use for NEs and tocilizumab only for CRS) was evaluated at 1 × 106 cells per kg KTE-X19. In the 9 patients treated under revised AE management, 33% had grade 3 CRS and 11% had grade 3 NEs, with no grade 4 or 5 NEs. The overall complete remission rate correlated with CAR T-cell expansion and was 83% in patients treated with 1 × 106 cells per kg and 69% in all patients. Minimal residual disease was undetectable in all responding patients. At a median follow-up of 22.1 months (range, 7.1-36.1 months), the median duration of remission was 17.6 months (95% confidence interval [CI], 5.8-17.6 months) in patients treated with 1 × 106 cells per kg and 14.5 months (95% CI, 5.8-18.1 months) in all patients. KTE-X19 treatment provided a high response rate and tolerable safety in adults with R/R B-ALL. Phase 2 is ongoing at 1 × 106 cells per kg with revised AE management. This trial is registered at www.clinicaltrials.gov as #NCT02614066.

Indexed as

Immunotherapy, AdoptiveAdolescentAdultAgedAntigens, CD19Biomarkers, TumorCell ProliferationCytokine Release SyndromeDisease-Free SurvivalDose-Response Relationship, DrugFemaleHumansInflammation MediatorsMaleMiddle AgedNeoplasm, ResidualAntigens, CD19Biomarkers, Tumorbrexucabtagene autoleucelInflammation MediatorsReceptors, Chimeric Antigen

Identifiers

PMID33827116
PMCPMC9999039
OpenAlexW3146763078

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.