CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336478
Recruitment Status : Withdrawn
First Posted : April 18, 2011
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Imperial College London

March 22, 2011
April 18, 2011
June 8, 2015
April 2011
June 2014   (Final data collection date for primary outcome measure)
Safety and toxicity donor CD56+CD3- NK cells [ Time Frame: Day 28 post NK cell infusion ]
To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE).
Same as current
Complete list of historical versions of study NCT01336478 on Archive Site
  • Donor neutrophil and platelet engraftment [ Time Frame: Day 28 post stem cell infusion ]
    Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)
  • Rates of acute GVHD (grade 2-4) [ Time Frame: Day 100 post stem cell infusion ]
    Risk of acute GVHD
  • Relapse rate [ Time Frame: 1 year post stem cell infusion ]
Same as current
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CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
Safety and Toxicity of Escalating Doses of Adoptively Infused ex Vivo Selected CD56+CD3- NK Cells on Day 7 Following Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies.
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Haematological Malignancies
  • Allogeneic Stem Cell Transplant
  • CD56+CD3- NK Cells
  • Procedure: Infusion of donor derived ex-vivo selected NK cells to patients after transplant
    Infusion of donor derived ex-vivo selected NK cells to patients after transplant
  • Procedure: Haematology / Blood chemistry sampling
    Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
Not Provided
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients undergoing an allogeneic HSCT from a sibling donor, as treatment for a hematological malignancy. The conditioning regimen, and in particular whether ablative or non ablative, will not be considered in the criteria for recruitment
  2. Patient and donor Age >18 years
  3. Patients and donors must have signed an informed consent form
  4. The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
  5. Donor must be fit to undergo leukapheresis

Exclusion Criteria:

  1. Life expectancy < 3 months
  2. ECOG performance status 3 or 4
  3. Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
  4. Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
  5. HIV-positive patients
  6. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Not Provided
Not Provided
Imperial College London
Imperial College London
Not Provided
Principal Investigator: Katy Rezvani, MD Imperial College Healthcare NHS Trust
Imperial College London
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP