CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
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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.
Condition or disease
Haematological MalignanciesAllogeneic Stem Cell TransplantCD56+CD3- NK Cells
Procedure: Infusion of donor derived ex-vivo selected NK cells to patients after transplantProcedure: Haematology / Blood chemistry sampling
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.
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).
Secondary Outcome Measures :
Donor neutrophil and platelet engraftment [ Time Frame: Day 28 post stem cell infusion ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Patient and donor Age >18 years
Patients and donors must have signed an informed consent form
The donor must be willing and capable of donating lymphocytes for NK selection using apheresis techniques
Donor must be fit to undergo leukapheresis
Life expectancy < 3 months
ECOG performance status 3 or 4
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia
Patients will not be eligible if they receive in vivo T depletion with ATG, ALG or campath-1H
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