Clinical trial NCT01336478: CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Haematological Malignancies
Allogeneic Stem Cell Transplant
CD56+CD3- NK Cells
Keywords: NK
natural killer
immunotherapy
leukemia
hematological malignancies
stem cell transplantation
adoptive therapy
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Safety and toxicity donor CD56+CD3- NK cells
timeFrame: Day 28 post NK cell infusion
Secondary outcomes:
measure: Donor neutrophil and platelet engraftment
timeFrame: Day 28 post stem cell infusion
measure: Rates of acute GVHD (grade 2-4)
timeFrame: Day 100 post stem cell infusion
measure: Relapse rate
timeFrame: 1 year post stem cell infusion
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Imperial College Healthcare NHS Trust
name: Katy Rezvani, MD
role: PRINCIPAL_INVESTIGATOR
References: