Human Leukocyte Antigen (HLA) Class I Haplotype Mismatched Natural Killer Cell Infusions

NCT00660166 | Completed Phase 1 DMC

• 1 other identifier: Allogeneic NKCell post ABMT
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to examine the safety of infusing escalated doses of allogeneic (from a relative of the patient), enriched natural killer (NK) cells after autologous (from the patient) stem cell transplantation. The hypothesis is that the infusion of these NK cells early after an autologous stem cell transplant will help to eliminate and eradicate any residual cancerous cells that remain in the body and may have survived the chemotherapy or radiation.

Conditions

Lymphoma; Myeloma; Leukemia

Keywords

Natural killer cells; autologous stem cell transplant; immunotherapy

Outcome Measures

Primary Outcomes (1)

• An evaluation of general safety will be undertaken: · Number of systemic clinical and biological adverse events occurring during the study. · Number of patients who prematurely discontinued study treatment for reasons linked to the general safety.

  58 days post infusion of allogeneic NK-cells

Secondary Outcomes (5)

• Duration of donor NK cells in the recipient's blood

  58 days post infusion of allogeneic NK-cells

• Patient survival at 100 days and at one year post treatment (all cause mortality)

  100 days and one year post treatment

• Occurrence of new cancer during the first year post infusion of allogeneic NK-cells

  One year post infusion of allogeneic NK-cells

• Documented systemic infections during the first 30 days post infusion of allogeneic NK-cells.

  30 days post infusion of allogeneic NK-cells

• Occurrence of other possible NK-infusions related complications such as,fever, capillary leak syndrome and/or allergic reaction.

  58 days post infusion of allogeneic NK-cells

Study Arms (1)

1

EXPERIMENTAL

Biological: NK-Cell Infusion

Interventions

NK-Cell Infusion BIOLOGICAL

The infusion of natural killer (NK) cells will be performed in the Infusion Center at New England Medical Center. The NK cells will be given to the subject intravenously (into a vein). In addition, a balanced salt solution will be infused beginning about two hours prior to and continuing for two hours after the infusion of NK cells to keep the fluid level in the body well balanced. The subject will also receive Benadryl by injection 15-30 minutes prior to infusion to counteract and prevent any unwanted allergic side effects. The subject will be observed for any side effects during this time. If the subject feels well, he/she can go home. However, there may be a requirement to keep him/her overnight.

1

Eligibility Criteria

• Age: 13 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have undergone an autologous stem cell transplant for the following diseases:
• Acute Myeloid Leukemia
• Non-Hodgkin's Lymphoma
• Hodgkin's Disease
• Multiple Myeloma
• Age 13 - 70 years old
• Able to give informed consent
• Hepatic and renal function: bilirubin less than or equal to 2x normal limits, AST and ALT less than or equal to 2x normal limits, serum creatinine less than or equal to 1.5x normal
• ECOG Performance Status less than or equal to 1 (at planned time of transplantation)
• Patients with no active infection

You may not qualify if:

• Patients who have not recovered sufficiently from the side effects of the autologous transplant (i.e. have \> grade 2 toxicity in any organ system)
• Patients who have insufficient engraftment parameters according to the following criteria: WBC \< 2,500 /mm3 and platelets \< 50,000/mm3
• Radiation therapy, chemotherapy, or immunotherapy beginning one week before NK-cell infusion and lasting 2 weeks after NK-cell infusion.
• Intrinsic impaired organ function (as stated above).
• Physical or psychiatric conditions that in the estimation of the PI or designee place the patient at high-risk of toxicity or non-compliance.
• Uncontrolled, life-threatening infections at the time of infusion.
• Concurrent treatment with corticosteroids and/or other immuno-suppressive drugs.

Sponsors & Collaborators

• Tufts Medical Center: lead
• University of Minnesota: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• Klingemann H, Boissel L. Targeted cellular therapy with natural killer cells. Horm Metab Res. 2008 Feb;40(2):122-5. doi: 10.1055/s-2007-1004576.

  PMID: 18283630 RESULT

• Klingemann HG. Natural killer cell-based immunotherapeutic strategies. Cytotherapy. 2005;7(1):16-22. doi: 10.1080/14653240510018000.

  PMID: 16040380 RESULT

MeSH Terms

Conditions

Lymphoma; Neoplasms, Plasma Cell; Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hematologic Diseases

Study Officials

• Hans Klingemann, MD, PhD

  Tufts Medical Center

  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: April 11, 2008
• First Posted: April 17, 2008
• Study Start: April 1, 2006
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 27, 2012

Record last verified: 2012-06

Locations

US (1)