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Study · Non-randomized trial · 2017

9 results

Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers-results of a dose escalation trial.

Karpova D, Bräuninger S, Wiercinska E, Krämer A, Stock B, Graff J, Martin H, Wach A, Escot C, Douglas G, Romagnoli B, Chevalier E, Dembowski K, Hooftman L, Bonig H

Journal of translational medicine3 Jan 2017Cited by 42 (Europe PMC)

PMID28049490 (opens in a new tab)PMCIDPMC5209880 (opens in a new tab)DOI10.1186/s12967-016-1107-2 (opens in a new tab)PepBankPUB-28049490
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Summary

BackgroundCertain disadvantages of the standard hematopoietic stem and progenitor cell (HSPC) mobilizing agent G-CSF fuel the quest for alternatives. We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.MethodsHealthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide. Safety, tolerability, pharmacokinetics and pharmacodynamics were assessed.ResultsBalixafortide was well tolerated and rated favorably over G-CSF by subjects. At all doses tested balixafortide mobilized HSPC. In the dose range between 1500 and 2500 µg/kg mobilization was similar, reaching 38.2 ± 2.8 CD34 + cells/µL (mean ± SEM). Balixafortide caused mixed leukocytosis in the mid-20 K/µL range. B-lymphocytosis was more pronounced, whereas neutrophilia and monocytosis were markedly less accentuated with balixafortide compared to G-CSF. At the 24 h time point, leukocytes had largely normalized.ConclusionsBalixafortide is safe, well tolerated, and induces efficient mobilization of HSPCs in healthy male volunteers. Based on experience with current apheresis technology, the observed mobilization at doses ≥1500 µg/kg of balixafortide is predicted to yield in a single apheresis a standard dose of 4× 10E6 CD34+ cells/kg from most individuals donating for an approximately weight-matched recipient. Exploration of alternative dosing regimens may provide even higher mobilization responses. Trial Registration European Medicines Agency (EudraCT-Nr. 2011-003316-23) and clinicaltrials.gov (NCT01841476).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanNon-randomized trialSafety outcome

    In healthy male volunteers, balixafortide was well tolerated.

    In plain wordsIn healthy male volunteers, balixafortide was well tolerated.

    Peptide
    Balixafortide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    Balixafortide was well tolerated and rated favorably over G-CSF by subjects.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  2. 02HumanNon-randomized trialActivity measurement

    In healthy male volunteers, subjects rated balixafortide favorably over G-CSF.

    In plain wordsIn healthy male volunteers, subjects rated balixafortide more favorably than G-CSF.

    Peptide
    Balixafortide
    Outcome
    IncreaseSubject treatment rating
    Study

    n: not reported in source

    Comparator
    G-CSF
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    Balixafortide was well tolerated and rated favorably over G-CSF by subjects.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  3. 03HumanNon-randomized trialActivity measurement

    In healthy male volunteers, balixafortide mobilized HSPC at all tested doses.

    In plain wordsIn healthy male volunteers, balixafortide mobilized blood stem and progenitor cells at all tested doses.

    Peptide
    Balixafortide
    Outcome
    IncreaseHSPC mobilization
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    At all doses tested balixafortide mobilized HSPC.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  4. 04HumanNon-randomized trialActivity measurement

    In healthy male volunteers, balixafortide mobilization was similar across 1500-2500 µg/kg, reaching 38.2 ± 2.8 CD34 + cells/µL.

    In plain wordsIn healthy male volunteers, balixafortide produced similar stem-cell mobilization across the reported higher dose range.

    Peptide
    Balixafortide
    Outcome
    Not applicableCD34-positive cell mobilization
    Study

    n: not reported in source

    Comparator
    balixafortide doses between 1500 and 2500 µg/kg
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    1500-2500 µg/kg · infusionAs given in this study (human).

    Measurements

    CD34 + cells
    38.2 cells/µL
    mean ± SEM 2.8 at 1500-2500 µg/kg

    Source sentences

    Summary
    In the dose range between 1500 and 2500 µg/kg mobilization was similar, reaching 38.2 ± 2.8 CD34 + cells/µL (mean ± SEM).
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  5. 05HumanNon-randomized trialActivity measurement

    In healthy male volunteers, balixafortide caused mixed leukocytosis in the mid-20 K/µL range.

    In plain wordsIn healthy male volunteers, balixafortide increased white blood cells.

    Peptide
    Balixafortide
    Outcome
    IncreaseMixed leukocytosis
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    Balixafortide caused mixed leukocytosis in the mid-20 K/µL range.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  6. 06HumanNon-randomized trialActivity measurement

    In healthy male volunteers, B-lymphocytosis was more pronounced with balixafortide than G-CSF.

    In plain wordsIn healthy male volunteers, balixafortide increased B lymphocytes more than G-CSF.

    Peptide
    Balixafortide
    Outcome
    IncreaseB-lymphocytosis
    Study

    n: not reported in source

    Comparator
    G-CSF
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    B-lymphocytosis was more pronounced, whereas neutrophilia and monocytosis were markedly less accentuated with balixafortide compared to G-CSF.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  7. 07HumanNon-randomized trialActivity measurement

    In healthy male volunteers, neutrophilia was less accentuated with balixafortide than G-CSF.

    In plain wordsIn healthy male volunteers, balixafortide caused less neutrophilia than G-CSF.

    Peptide
    Balixafortide
    Outcome
    DecreaseNeutrophilia
    Study

    n: not reported in source

    Comparator
    G-CSF
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    B-lymphocytosis was more pronounced, whereas neutrophilia and monocytosis were markedly less accentuated with balixafortide compared to G-CSF.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  8. 08HumanNon-randomized trialActivity measurement

    In healthy male volunteers, monocytosis was less accentuated with balixafortide than G-CSF.

    In plain wordsIn healthy male volunteers, balixafortide caused less monocytosis than G-CSF.

    Peptide
    Balixafortide
    Outcome
    DecreaseMonocytosis
    Study

    n: not reported in source

    Comparator
    G-CSF
    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    B-lymphocytosis was more pronounced, whereas neutrophilia and monocytosis were markedly less accentuated with balixafortide compared to G-CSF.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.
  9. 09HumanNon-randomized trialActivity measurement

    In healthy male volunteers receiving balixafortide, leukocytes had largely normalized at 24 h.

    In plain wordsIn healthy male volunteers receiving balixafortide, white blood cells largely returned to normal at 24 hours.

    Peptide
    Balixafortide
    Outcome
    Not applicableLeukocyte normalization
    Study

    n: not reported in source

    Outcome group
    Immune response · Immune and inflammation
    Studied dose
    500-2500 µg/kg · infusionAs given in this study (human).

    Source sentences

    Summary
    At the 24 h time point, leukocytes had largely normalized.
    2 context sentences
    Summary · context
    We herein report results of a Phase I dose escalation trial comparing mobilization with a peptidic CXCR4 antagonist POL6326 (balixafortide) vs. G-CSF.
    Summary · context
    Healthy male volunteer donors with a documented average mobilization response to G-CSF received, following ≥6 weeks wash-out, a 1-2 h infusion of 500-2500 µg/kg of balixafortide.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT01841476

Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

Polyphor Ltd.n = 27Feb 2012 to Sept 2015

Healthy

Trial pageClinicalTrials.govUpdated 25 Nov 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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