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Cited by 1,862CAR-T cell therapy researchLymphoma Diagnosis and TreatmentT-cell and B-cell Immunology

KTE-X19 CAR T cell therapy in relapsed or refractory mantle-cell lymphoma

Open access
Wang, Michael, Munoz, Javier, Goy, Andre, Locke, Frederick L., Jacobson, Caron A., Hill, Brian T., Timmerman, John M., Holmes, Houston +17 more·2020·New England Journal of Medicine
DOI 10.1056/nejmoa1914347PMC PMC7731441
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Abstract

BACKGROUND: Patients with relapsed or refractory mantle-cell lymphoma who have disease progression during or after the receipt of Bruton's tyrosine kinase (BTK) inhibitor therapy have a poor prognosis. KTE-X19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, may have benefit in patients with relapsed or refractory mantle-cell lymphoma. METHODS: CAR T cells per kilogram of body weight. The primary end point was the percentage of patients with an objective response (complete or partial response) as assessed by an independent radiologic review committee according to the Lugano classification. Per the protocol, the primary efficacy analysis was to be conducted after 60 patients had been treated and followed for 7 months. RESULTS: A total of 74 patients were enrolled. KTE-X19 was manufactured for 71 patients and administered to 68. The primary efficacy analysis showed that 93% (95% confidence interval [CI], 84 to 98) of the 60 patients in the primary efficacy analysis had an objective response; 67% (95% CI, 53 to 78) had a complete response. In an intention-to-treat analysis involving all 74 patients, 85% had an objective response; 59% had a complete response. At a median follow-up of 12.3 months (range, 7.0 to 32.3), 57% of the 60 patients in the primary efficacy analysis were in remission. At 12 months, the estimated progression-free survival and overall survival were 61% and 83%, respectively. Common adverse events of grade 3 or higher were cytopenias (in 94% of the patients) and infections (in 32%). Grade 3 or higher cytokine release syndrome and neurologic events occurred in 15% and 31% of patients, respectively; none were fatal. Two grade 5 infectious adverse events occurred. CONCLUSIONS: KTE-X19 induced durable remissions in a majority of patients with relapsed or refractory mantle-cell lymphoma. The therapy led to serious and life-threatening toxic effects that were consistent with those reported with other CAR T-cell therapies. (Funded by Kite, a Gilead company; ZUMA-2 ClinicalTrials.gov number, NCT02601313.).

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  • CAR T-cells elicited complete responses in 32-67% of lymphoma patients and showed better complete response rates in patients with leukemia.

    “These CAR T-cells were able to elicit complete responses (CR) in 32-67% of lymphoma patients and showed better CR rates in patients with leukemia (16-19).”

    From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [18]

    The Results > Efficacy section reports a 67% complete-response rate among 60 treated patients with relapsed or refractory mantle-cell lymphoma. It does not establish the 32% lower end of the range or compare complete-response rates with those in leukemia patients. Page numbers are not available in our copy. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

  • Most CAR T cell trials to date have used autologous peripheral blood and apheresis as the main cell sources for manufacturing.

    “First, most CAR T cell trials to date have used autologous peripheral blood and apheresis as the main cell sources for manufacturing (9-18,21,22).”

    From Scalable Manufacturing of CAR T Cells for Cancer Immunotherapy (2021) · cites this paper as [18]

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Authors
Wang, M., Munoz, J., Goy, A., Locke, F. L., Jacobson, C. A., Hill, B. T., Timmerman, J. M., Holmes, H., Jaglowski, S., Flinn, I. W., McSweeney, P. A., Miklos, D. B., Pagel, J. M., Kersten, M.-J., Milpied, N., Fung, H., Topp, M. S., Houot, R., Beitinjaneh, A., Peng, W., Zheng, L., Rossi, J. M., Jain, R. K., Rao, A. V., & Reagan, P. M.
Affiliations
  • Cleveland Clinic (US)
  • From the University of Texas M.D. Anderson Cancer Center, Houston (M.W.), and Texas Oncology, Dallas (H.H.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (J.M.); John Theurer Cancer Center, Hackensack, NJ (A.G.); Moffitt Cancer Center, Tampa (F.L.L.), and the University of Miami, Miami (A.B.) — both in Florida; Dana–Farber Cancer Institute, Boston (C.A.J.); Cleveland Clinic Foundation, Cleveland (B.T.H.), and the Ohio State University Comprehensive Cancer Center, Columbus (S.J.); David Geffen...
  • Fox Chase Cancer Center (US)
Corresponding author
Wang, Michael
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2020-04-02
Volume
382
Issue
14
Pages
1331-1342
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa1914347
PMC
PMC7731441
OpenAlex
W3014583893
Cited by
1,862
References
30
Citations by year
2026: 203 · 2025: 249 · 2024: 314 · 2023: 321 · 2022: 366 · 2021: 321 · 2020: 81 · 2012: 1
FWCI
98.43
Type
journal article
Language
en
Open access
Licence
www.nejmgroup.org/legal/terms-of-use.htm (vor)
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
  • Data Archiving and Networked Services (DANS) (submittedVersion)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
Funders
Kite, a Gilead Company
Topics
  • Health Sciences › Medicine › Oncology › CAR-T cell therapy research
  • Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
  • Life Sciences › Immunology and Microbiology › Immunology › T-cell and B-cell Immunology
Keywords
tisagenlecleucel, CD19 CAR T-cell therapy, BTK inhibitor resistance, objective response, complete response, progression-free survival, overall survival, cytokine release syndrome, neurological adverse events, cytopenia
MeSH terms
Receptors, Chimeric Antigen, Adult, Aged, Antineoplastic Agents, Combined Modality Therapy, Humans, Infusions, Intravenous, Leukapheresis, Middle Aged, Recurrence, T-Lymphocytes, Vidarabine, Survival Analysis, Immunotherapy, Adoptive, Antigens, CD19, Lymphoma, Mantle-Cell

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