Evidence map›Paper›PMID 25915810›Full record

ArticleBone marrow transplantation2015

Efficacy and safety of CDX-301, recombinant human Flt3L, at expanding dendritic cells and hematopoietic stem cells in healthy human volunteers.

N Anandasabapathy, G Breton, A Hurley, M Caskey, C Trumpfheller, P Sarma, J Pring, M Pack, N Buckley, I Matei and 8 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Bone marrow transplantation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01465139 (A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301), which is not on this map. Cited by 66 papers.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

NCT01465139 phase1completednot on this map

A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

TypeinterventionalSponsorCelldex TherapeuticsRan2011 to 2013Enrolled30ConditionsHealthyArmsCDX-301
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 104 citations in OpenAlex.

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  12. Cytokines in cancer.Cancer cell · 2025
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  18. Phase I Study of GS-3583, an FMS-like Tyrosine Kinase 3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
  19. Article
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6 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

18 authors at 3 institutions in 1 country.

N Anandasabapathy1] The Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA [2] Department of Dermatology, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
G BretonThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
A HurleyThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
M CaskeyThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
C TrumpfhellerThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
P SarmaThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
J PringThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
M PackThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
N BuckleyThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
I MateiDepartment of Pediatrics, Weill Cornell Medical College, New York, NY, USA.
D LydenDepartment of Pediatrics, Weill Cornell Medical College, New York, NY, USA.
J GreenCelldex Therapeutics, Inc., Needham, MA, USA.
T HawthorneCelldex Therapeutics, Inc., Needham, MA, USA.
H C MarshCelldex Therapeutics, Inc., Needham, MA, USA.
M YellinCelldex Therapeutics, Inc., Needham, MA, USA.
T DavisCelldex Therapeutics, Inc., Needham, MA, USA.
T KelerCelldex Therapeutics, Inc., Needham, MA, USA.
S J SchlesingerThe Laboratory of Cellular Physiology and Immunology, The Rockefeller University, New York, NY, USA.
Rockefeller University · USCelldex Therapeutics (United States) · USCornell University · US

Funding

Transforming Translational Science and Education to Benefit Human HealthUL1TR000043 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$26.8M
Understanding B cell memory in response to diverse virus infectionsU19AI111825 · NIAID · ROCKEFELLER UNIVERSITY · PI RAVETCH, JEFFREY VICTOR · 2014 to 2023
$26.0M
Transforming Translational Science and Education to Benefit Human HealthKL2TR000151 · NCATS · ROCKEFELLER UNIVERSITY · PI COLLER, BARRY · 2012 to 2015
$2.1M
The clinical use of Flt3L - an immune adjuvant to potentiate Dendritic CellsK23AR063461 · NIAMS · ROCKEFELLER UNIVERSITY · PI ANANDASABAPATHY, NIROSHANA · 2012 to 2016
$726k
NCATS NIH HHS KL2 TR000151NCATS NIH HHS UL1 TR000043NCATS NIH HHS UL1TR000043/KL2TR000151NIAID NIH HHS U19 AI111825NIAID NIH HHS U19AI111825NIAMS NIH HHS AR063461-01A1NIAMS NIH HHS K23 AR063461
6 · The paper itself

Abstract

Fms-like tyrosine kinase-3 ligand (Flt3L) uniquely binds the Flt3 (CD135) receptor expressed on hematopoietic stem cells (HSCs), early progenitor cells, immature thymocytes and steady-state dendritic cells (DCs) and induces their proliferation, differentiation, development and mobilization in the bone marrow, peripheral blood and lymphoid organs. CDX-301 has an identical amino-acid sequence and comparable biological activity to the previously tested rhuFlt3L, which ceased clinical development over a decade ago. This Phase 1 trial assessed the safety, pharmacokinetic, pharmacodynamic and immunologic profile of CDX-301, explored alternate dosing regimens and examined the impact of rhuFlt3L on key immune cell subsets. Thirty healthy volunteers received CDX-301 (1-75 μg/kg/day) over 5-10 days. One event of Grade 3 community-acquired pneumonia occurred. There were no other infections, dose-limiting toxicities or serious adverse events. CDX-301 resulted in effective peripheral expansion of monocytes, hematopoietic stem and progenitor cells and key subsets of myeloid DCs and plasmacytoid DCs, with no clear effect on regulatory T cells. These data from healthy volunteers support the potential for CDX-301, as monotherapy or in combination with other agents, in various indications including allogeneic HSC transplantation and immunotherapy, but the effects of CDX-301 will need to be investigated in each of these patient populations.

Indexed as

AdolescentAdultDendritic CellsFemalefms-Like Tyrosine Kinase 3Healthy VolunteersHematopoietic Stem Cell TransplantationHumansMaleMiddle AgedTransplantation ConditioningYoung AdultFLT3 protein, humanfms-Like Tyrosine Kinase 3

Identifiers

PMID25915810
PMCPMC4532305
OpenAlexW1996922969

What OpenQuestion holds

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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.