CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

Allogeneic Stem Cell Transplant Clinical Trial

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01336478
• Other study ID #: JROHH0203
• Status: Withdrawn
• Phase: Phase 1
• First received: March 22, 2011
• Last updated: June 3, 2015
• Start date: April 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2012
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplant
• CD56+CD3- NK Cells
• Haematological Malignancies
• Hematologic Neoplasms
• Neoplasms

Intervention

Procedure:
• Infusion of donor derived ex-vivo selected NK cells to patients after transplant
Infusion of donor derived ex-vivo selected NK cells to patients after transplant
• Haematology / Blood chemistry sampling
Haematology / Blood chemistry sampling, collection of blood for ancillary lab research

Locations

Country	Name	City	State
United Kingdom	Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Donor neutrophil and platelet engraftment	Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L)	Day 28 post stem cell infusion	Yes
Secondary	Rates of acute GVHD (grade 2-4)	Risk of acute GVHD	Day 100 post stem cell infusion	Yes
Secondary	Relapse rate	Relapse	1 year post stem cell infusion	Yes