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

Tufts University

Status and phase

Completed

Phase 1

Conditions

Lymphoma

Myeloma

Leukemia

Treatments

Biological: NK-Cell Infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00660166

Allogeneic NKCell post ABMT

Details and patient eligibility

About

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.

Full description

Natural killer cells are blood cells that are responsible for eliminating cancer cells especially when there are only a few. It has been shown that NK cells coming from a "mismatched" person (a relative) have a better chance than the patient's own NK cells to recognize and kill cancer cells. These cells will be collected from the blood of a parent, child or sibling and after preparation in the laboratory, will be given to the patient early after an autologous stem cell transplantation like a blood or platelet transfusion. A person who has been diagnosed with a blood tumor and received an autologous stem cell transplant has the chance of his/her cancer coming back. This study uses NK cells obtained from a relative to prevent disease recurrence by potentially eliminating and eradicating any residual cancerous cells.

Enrollment

13 patients

Sex

All

Ages

13 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.