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.
18 Years
N/A
Both
Haematological Malignancies, Allogeneic Stem Cell Transplant, CD56+CD3- NK Cells
Trial Information
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and toxicity donor CD56+CD3- NK cells
Outcome Description:
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).
Outcome Time Frame:
Day 28 post NK cell infusion
Safety Issue:
Yes
Principal Investigator
Katy Rezvani, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Imperial College Healthcare NHS Trust
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
JROHH0203
NCT ID:
NCT01336478
Start Date:
April 2011
Completion Date:
June 2014
Related Keywords:
- Haematological Malignancies
- Allogeneic Stem Cell Transplant
- CD56+CD3- NK Cells
- NK
- natural killer
- immunotherapy
- leukemia
- hematological malignancies
- stem cell transplantation
- adoptive therapy
- Neoplasms
- Hematologic Neoplasms
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