Back to resultsCD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
Primary Purpose
Haematological Malignancies, Allogeneic Stem Cell Transplant, CD56+CD3- NK Cells
Status
Withdrawn
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Haematology / Blood chemistry sampling
Sponsored by
About this trial
This is an interventional treatment trial for Haematological Malignancies focused on measuring NK, natural killer, immunotherapy, leukemia, hematological malignancies, stem cell transplantation, adoptive therapy
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- HIV-positive patients
- 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
Sites / Locations
- Hammersmith Hospital
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Donor neutrophil and platelet engraftment
Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)
Rates of acute GVHD (grade 2-4)
Risk of acute GVHD
Relapse rate
Relapse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01336478
Brief Title
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
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Withdrawn
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2014 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancies, Allogeneic Stem Cell Transplant, CD56+CD3- NK Cells
Keywords
NK, natural killer, immunotherapy, leukemia, hematological malignancies, stem cell transplantation, adoptive therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Intervention Description
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Intervention Type
Procedure
Intervention Name(s)
Haematology / Blood chemistry sampling
Intervention Description
Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
Primary Outcome Measure Information:
Title
Safety and toxicity donor CD56+CD3- NK cells
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).
Time Frame
Day 28 post NK cell infusion
Secondary Outcome Measure Information:
Title
Donor neutrophil and platelet engraftment
Description
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
Title
Rates of acute GVHD (grade 2-4)
Description
Risk of acute GVHD
Time Frame
Day 100 post stem cell infusion
Title
Relapse rate
Description
Relapse
Time Frame
1 year post stem cell infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
HIV-positive patients
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katy Rezvani, MD
Organizational Affiliation
Imperial College Healthcare NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation
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