Evidence map›Paper›PMID 31110096›Full record

ArticleBMJ open2019

Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector: a unicentre phase I/II clinical trial protocol.

Maria-Luisa Schubert, Anita Schmitt, Leopold Sellner, Brigitte Neuber, Joachim Kunz, Patrick Wuchter, Alexander Kunz, Ulrike Gern, Birgit Michels, Susanne Hofmann and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03676504 (Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial), which is not on this map. Cited by 27 papers.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed
2.8field-weighted citation impact, top 8% 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.

NCT03676504 phase1 / phase2recruitingnot on this map

Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial

TypeinterventionalSponsorUniversity Hospital HeidelbergRan2018 to 2027Enrolled68ConditionsAcute Lymphoblastic Leukemia, Adult, Acute Lymphoblastic Leukemia, Pediatric, Chronic Lymphocytic Leukemia, Diffuse Large B Cell LymphomaArmsCD19.CAR T Cells, Fludarabine, Cyclophosphamide
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 40 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
  4. Cellular therapies in rheumatic and musculoskeletal diseases.Journal of translational autoimmunity · 2025
    Review
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Phase I CAR-T Clinical Trials Review.Anticancer research · 2022
    Review
  14. Article
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
  20. Article
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

16 authors at 4 institutions in 1 country.

Maria-Luisa SchubertDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Anita SchmittDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Leopold SellnerDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Brigitte NeuberDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Joachim KunzDepartment of Pediatric Hematology, Oncology and Immunology, Children's Hospital, Heidelberg University Hospital, Heidelberg, Germany.
Patrick WuchterInstitute of Transfusion Medicine and Immunology, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany.
Alexander KunzDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Ulrike GernDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Birgit MichelsDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Susanne HofmannDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Angela Hückelhoven-KraussDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Andreas KulozikDepartment of Pediatric Hematology, Oncology and Immunology, Children's Hospital, Heidelberg University Hospital, Heidelberg, Germany.
Anthony D HoDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Carsten Müller-TidowDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Peter DregerDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Michael SchmittDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg University · DEUniversity Hospital Heidelberg · DENational Center for Tumor Diseases · DEUniversity Medical Centre Mannheim · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChimeric antigen receptor (CAR) T cells spark hope for patients with CD19+ B cell neoplasia, including relapsed or refractory (r/r) acute lymphoblastic leukaemia (ALL) or r/r non-Hodgkin's lymphoma (NHL). Published studies have mostly used second-generation CARs with 4-1BB or CD28 as costimulatory domains. Preclinical results of third-generation CARs incorporating both elements have shown superiority concerning longevity and proliferation. The University Hospital of Heidelberg is the first institution to run an investigator-initiated trial (IIT) CAR T cell trial (Heidelberg Chimeric Antigen Receptor T cell Trial number 1 [HD-CAR-1]) in Germany with third-generation CD19-directed CAR T cells. METHODS AND ANALYSIS: Adult patients with r/r ALL (stratum I), r/r NHL including chronic lymphocytic leukaemia, diffuse large B-cell lymphoma, follicular lymphoma or mantle cell lymphoma (stratum II) as well as paediatric patients with r/r ALL (stratum III) will be treated with autologous T-lymphocytes transduced by third-generation RV-SFG.CD19.CD28.4-1BB zeta retroviral vector (CD19.CAR T cells). The main purpose of this study is to evaluate safety and feasibility of escalating CD19.CAR T cell doses (1-20×10 ETHICS AND DISSEMINATION: Ethical approval and approvals from the local and federal competent authorities were granted. Trial results will be reported via peer-reviewed journals and presented at conferences and scientific meetings. TRIAL REGISTRATION NUMBER: Eudra CT 2016-004808-60; NCT03676504; Pre-results.

Indexed as

AdultAntigens, CD19CD28 AntigensCell- and Tissue-Based TherapyClinical Trials, Phase I as TopicClinical Trials, Phase II as TopicFemaleHumansImmunotherapy, AdoptiveLymphomaMaleMiddle AgedProspective StudiesReceptors, Antigen, T-CellT-LymphocytesAntigens, CD19CD28 AntigensReceptors, Antigen, T-Cell4-1bb (cd137), Cd28 Costimulatory DomainsCD19 CAR T cellsrefractory Or relapsed leukaemia and lymphomathird-generation car T cells

Identifiers

PMID31110096
PMCPMC6530404
OpenAlexW2945824414

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.