Evidence map›Paper›PMID 40180925›Full record

Trial reportBlood cancer journal2025

Donor-derived CARCIK-CD19 cells engineered with Sleeping Beauty transposon in acute lymphoblastic leukemia relapsed after allogeneic transplantation.

Federico Lussana, Chiara F Magnani, Stefania Galimberti, Giuseppe Gritti, Giuseppe Gaipa, Daniela Belotti, Benedetta Cabiati, Sara Napolitano, Silvia Ferrari, Alex Moretti and 23 more

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Blood cancer journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Advancing Immunotherapy in Chronic Lymphocytic Leukemia.International journal of molecular sciences · 2026
    Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Review
  10. Review
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

33 authors.

Federico Lussana *Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0002-6510-8616
Chiara F Magnani *Tettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.ORCID 0000-0003-2474-2159
Stefania GalimbertiDepartment of Medicine and Surgery, Bicocca Bioinformatics, Biostatistics and Bioimaging Centre B4, University of Milano-Bicocca, Milan, Italy.
Giuseppe GrittiHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0002-6789-5123
Giuseppe GaipaTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Daniela BelottiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Benedetta CabiatiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Sara NapolitanoDepartment of Pediatrics, University of Milano-Bicocca, Fondazione MBBM, Monza, Italy.
Silvia FerrariHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Alex MorettiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Chiara BuracchiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.ORCID 0000-0002-5345-7448
Gian Maria BorleriHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Benedetta RambaldiHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Giuliana RizzutoHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Anna GrassiHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Muriel PaganessiHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Cristian MeliHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Sarah TettamantiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Giulia RiscaBiostatistics and Clinical Epidemiology, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Giulia PaisSan Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Giulio SpinozziSan Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Fabrizio BenedicentiSan Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Giovanni CazzanigaTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Chiara CapelliUSS Centro di Terapia Cellulare "G. Lanzani", Bergamo, Italy.
Elisa GottiUSS Centro di Terapia Cellulare "G. Lanzani", Bergamo, Italy.
Martino IntronaHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Josée GolayHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.
Eugenio MontiniSan Raffaele Telethon Institute for Gene Therapy, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Adriana BalduzziDepartment of Pediatrics, University of Milano-Bicocca, Fondazione MBBM, Monza, Italy.
Maria Grazia ValsecchiDepartment of Medicine and Surgery, Bicocca Bioinformatics, Biostatistics and Bioimaging Centre B4, University of Milano-Bicocca, Milan, Italy.
Giuseppe DastoliTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Alessandro RambaldiHematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.ORCID 0000-0002-3739-7502
Andrea BiondiTettamanti Center, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy. abiondi.unimib@gmail.com.ORCID 0000-0002-6757-6173

Funding

Associazione Italiana per la Ricerca sul Cancro (Italian Association for Cancer Research) 29175Associazione Italiana per la Ricerca sul Cancro (Italian Association for Cancer Research) 5×1000 Immunity in Cancer Spreading and Metastasis #21147Associazione Italiana per la Ricerca sul Cancro (Italian Association for Cancer Research) IG 2017:20564Ministero della Salute (Ministry of Health, Italy) PNC-E3-2022-23683269 PNC-HLS-TAMinistero dell'Istruzione, dell'Università e della Ricerca (Ministry of Education, University and Research) CN00000041 - CENTRO NAZIONALE SULLO SVILUPPO DI TERAPIA GENICA E FARMACI CON TECNOLOGIA A RNAMinistry of Health, Italy | Agenzia Italiana del Farmaco, Ministero della Salute (Italian Medicines Agency) TRS-2019-00002022
6 · The paper itself

Abstract

Non-viral engineering can ease CAR-T cell production and reduce regulatory and cost requirements. We utilized Sleeping Beauty transposon to engineer donor-derived anti-CD19.CD28.OX40.CD3zeta T cells differentiated in cytokine-induced killer (CARCIK-CD19) for B-cell precursor acute lymphoblastic leukemia (BCP-ALL) patients relapsed after allogeneic hematopoietic stem cell transplantation (alloHSCT). We report the results of CARCIK-CD19 observed in 36 patients (4 children and 32 adults) treated according to the final recommended dose. Cytokine release syndrome of grade 2 or lower occurred in 15 patients, ICANS grade 2 in 1 patient, and late-onset peripheral neurotoxicity of grade 3 in 2 patients. GVHD never occurred after treatment with allogeneic CARCIK-CD19. Complete remission was achieved by 30 out of 36 patients (83.3%), with MRD negativity in 89% of responders. With a median follow-up of 2.2 years, the 1-year overall survival was 57.0%, and event-free survival was 32.0%. The median duration of response at 1 year was 38.6%. CAR-T cells expanded rapidly after infusion and remained detectable for over 2 years. Integration site analysis after infusion showed a high clonal diversity. These data demonstrated that SB-engineered CAR-T cells are safe and induce durable remission in heavily pretreated patients with BCP-ALL relapsed after alloHSCT. Trial registration: The phase 1/2 and phase II trials are registered at www.clinicaltrials.gov as NCT#03389035 and NCT#05252403.

Indexed as

Antigens, CD19Cytokine-Induced Killer CellsDNA Transposable ElementsHematopoietic Stem Cell TransplantationImmunotherapy, AdoptivePrecursor Cell Lymphoblastic Leukemia-LymphomaTransposasesAdolescentAdultChildChild, PreschoolFemaleHumansMaleMiddle AgedRecurrenceAntigens, CD19DNA Transposable Elementssleeping beauty transposase, humanTransposases

Identifiers

PMID40180925
PMCPMC11968829

What OpenQuestion holds

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Registered trials

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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.