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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
Hammersmith Hospital
London, United Kingdom
Safety and toxicity donor CD56+CD3- NK cells
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).
Time frame: Day 28 post NK cell infusion
Donor neutrophil and platelet engraftment
Donor neutrophil engraftment (Neut \> 0.5 x10\^9/L) and platelet engraftment (Plt \> 20 x10\^9/L)
Time frame: Day 28 post stem cell infusion
Rates of acute GVHD (grade 2-4)
Risk of acute GVHD
Time frame: Day 100 post stem cell infusion
Relapse rate
Relapse
Time frame: 1 year post stem cell infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.