CD56+CD3- NK Cells Following Allogeneic Stem Cell Transplantation

NCT01336478 | Withdrawn Phase 1

• 1 other identifier: JROHH0203
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Haematological Malignancies; Allogeneic Stem Cell Transplant; CD56+CD3- NK Cells

Keywords

NK; natural killer; immunotherapy; leukemia; hematological malignancies; stem cell transplantation; adoptive therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Donor neutrophil and platelet engraftment

  Day 28 post stem cell infusion

• Rates of acute GVHD (grade 2-4)

  Day 100 post stem cell infusion

• Relapse rate

  1 year post stem cell infusion

Interventions

Infusion of donor derived ex-vivo selected NK cells to patients after transplant PROCEDURE

Infusion of donor derived ex-vivo selected NK cells to patients after transplant

Haematology / Blood chemistry sampling PROCEDURE

Haematology / Blood chemistry sampling, collection of blood for ancillary lab research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site

Study Officials

• Katy Rezvani, MD

  Imperial College Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: April 18, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 8, 2015

Record last verified: 2012-03

Locations

GB (1)