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.
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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).
Day 28 post NK cell infusion
Katy Rezvani, MD
Imperial College Healthcare NHS Trust
United Kingdom: Medicines and Healthcare Products Regulatory Agency