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Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation

NCT01853358 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of our study will be to determine the clinical and biological safety of infusing immuno-selected NK (Natural Killer) CD3-/CD56+ cells, early after allogeneic transplantation with colony stimulating factor (G-CSF) mobilized peripheral blood stem cells and Reduced Intensity Conditioning (RIC), as a potential substitute to usual "Donor Lymphocyte Infusion" (DLI), that contain the whole range of immune effectors. The trial will include several progressive steps: dose escalation up to a level compatible with the cost-effectiveness potential of the device and clinical situation and recombinant interleukin-2 (r-IL2) activation of selected NK cells in vitro prior to re-infusion.

Conditions

  • Hematological Malignancy

Interventions

BIOLOGICAL

NK Cell infusion

* level 1: 1 x 10e6 NK cells /kg; * level 2: 5 x 10e6 NK cells /kg; * level 3: \> 5.10e6 and ≤ 5.10e7 cellules NK/kg

Sponsors & Collaborators

  • Institut Paoli-Calmettes

    lead OTHER

Principal Investigators

  • BLAISE Didier, MD PhD · Institut Paoli-Calmettes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2018-03-15
Completion
2018-03-15

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01853358 on ClinicalTrials.gov