Evidence map›Paper›PMID 38467031›Full record

Trial reportBlood advances2024

Adoptive transfer of donor B lymphocytes: a phase 1/2a study for patients after allogeneic stem cell transplantation.

Julia Winkler, Hannes Tittlbach, Andrea Schneider, Ingrid Vasova, Julian Strobel, Susanne Herold, Stefanie Maas, Bernd M Spriewald, Roland Repp, Lambros Kordelas and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02007811 (Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02007811 phase1 / phase2unknown statusnot on this map

Prospective, Open-label, Multicentre Clinical Trial, Phase I/IIa, to Investigate the Safety and Tolerability of Allogeneic B-cell Concentrates CD3+-Depleted, CD19+-Enriched, Cryopreserved (Single Administration After Day 120 Following Allogeneic Stem Cell Transplantation (SCT), Donor-identical) in 4 Groups With Escalating Doses for Immune Response Enhancement, Measured as Response to a Antedated Single Vaccination

TypeinterventionalSponsorUniversity of Erlangen-Nürnberg Medical SchoolRan2013 to 2015Enrolled15ConditionsAcute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Chronic Myeloid Leukemia, Non Hodgkin's LymphomaArmsallogeneic donor derived B-lymphocytes
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

15 authors.

Julia WinklerDepartment of Internal Medicine 5 - Haematology and Oncology, University Hospital Erlangen, Erlangen, Germany.
Hannes TittlbachDepartment of Internal Medicine 5 - Haematology and Oncology, University Hospital Erlangen, Erlangen, Germany.
Andrea SchneiderDivision of Genetics, Department for Biology, Nikolaus-Fiebiger-Center for Molecular Medicine, Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Erlangen, Germany.
Ingrid VasovaDepartment of Internal Medicine 5 - Haematology and Oncology, University Hospital Erlangen, Erlangen, Germany.
Julian StrobelDepartment of Transfusion Medicine and Haemostaseology, University Hospital Erlangen, Erlangen, Germany.ORCID 0000-0002-1117-0350
Susanne HeroldCenter for Clinical Studies Erlangen, University Hospital Erlangen, Erlangen, Germany.
Stefanie MaasCenter for Clinical Studies Erlangen, University Hospital Erlangen, Erlangen, Germany.
Bernd M SpriewaldDepartment of Internal Medicine 5 - Haematology and Oncology, University Hospital Erlangen, Erlangen, Germany.
Roland ReppMedical Department 2, City Hospital Kiel, Kiel, Germany.
Lambros KordelasDepartment of Bone Marrow Transplantation, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Michael MachInstitute for Clinical and Molecular Virology, University Hospital Erlangen, Erlangen, Germany.
Daniel WolffDepartment of Hematology and Medical Oncology, University Hospital Regensburg, Regenburg, Germany.
Matthias EdingerDepartment of Hematology and Medical Oncology, University Hospital Regensburg, Regenburg, Germany.
Andreas MackensenDepartment of Internal Medicine 5 - Haematology and Oncology, University Hospital Erlangen, Erlangen, Germany.ORCID 0000-0002-0685-4483
Thomas H WinklerDivision of Genetics, Department for Biology, Nikolaus-Fiebiger-Center for Molecular Medicine, Friedrich-Alexander-University Erlangen-Nuremberg (FAU), Erlangen, Germany.ORCID 0000-0002-1860-0528

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractImmune reconstitution after allogeneic hematopoietic stem cell transplantation (allo-HSCT) is slow and patients carry a high and prolonged risk of opportunistic infections. We hypothesized that the adoptive transfer of donor B cells can foster after HSCT immuno-reconstitution. Here, we report, to our knowledge, the results of a first-in-human phase 1/2a study aimed to evaluate the feasibility and safety of adoptively transferred donor B cells and to test their activity upon recall vaccination. Good manufactoring practice (GMP) B-cell products were generated from donor apheresis products using 2-step magnetic cell separation. Fifteen patients who had undergone allo-HSCT were enrolled and treated after taper of immunosuppression (median, day +148; range, 130-160). Patients received 4 different doses of B cells (0.5 × 106 to 4.0 × 106 B cells per kg body weight). To test the activity of infused donor memory B cells in vivo, patients were vaccinated with a pentavalent vaccine 7 days after B-cell transfer. We observed the mobilization of plasmablasts and an increase in serum titers against vaccine antigens, with a stronger response in patients receiving higher B-cell numbers. Analysis of immunoglobulin VH-sequences by next-generation sequencing revealed that plasmablasts responding to vaccination originated from memory B-cell clones from the donor. Donor B-cell transfer was safe, as no Epstein-Barr virus (EBV) reactivation was observed, and only low-grade graft-versus-host disease (GVHD) occurred in 4 out of 15 patients. This pilot trial may pave the way for further studies exploring the adoptive transfer of memory B cells to reduce the frequency of infections after allo-HSCT. This trial was registered at ClinicalTrial.gov as #NCT02007811.

Indexed as

Adoptive TransferB-LymphocytesHematopoietic Stem Cell TransplantationTransplantation, HomologousAdultFemaleGraft vs Host DiseaseHumansMaleMiddle AgedTissue DonorsYoung Adult

Identifiers

PMID38467031
PMCPMC11127194

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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.