Pilot Study of Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia

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Research

Protocol

NKCD19: Pilot Study of Genetically Modified Haploidentical Natural Killer Cell Infusions for B-Lineage Acute Lymphoblastic Leukemia

Diseases

Stem Cell / Bone Marrow Transplant : Acute lymphoblastic leukemia (ALL)

Description

This protocol details about B-Lineage Acute Lymphoblastic Leukemia that had come back or is not responding to standard treatment. NK cells are a type of lymphocyte (a white blood cell) within the body’s immune (infection fighting) system. They specifically target cells in the body that are infected by viruses, helping to stop the viruses from spreading. NK cells have also been found to attack and “kill” some cancer cells. The NK cells used in this study will come from the blood of a family member donor. The donated NK cells that you will receive will be genetically modified (altered or changed) through the use of an inactivated (not able to function) virus called a vector. Because receipt of a genetically modified cell product is a fairly new area of science and medicine, doctors need to make sure it is safe when studied as a possible treatment for diseases. The purpose of this study is to find out what is the highest dose of genetically modified NK cells that can be safely infused

Objectives

To find out what is the safest dose of genetically modified NK cells that can be given to participants with B-lineage ALL. This will be done through the process called dose escalation.
To learn about how these genetically modified NK cells work and how long they survive in participants who receive this study intervention.
To gain knowledge about the effect of genetically modified donor NK cells on the disease of participants who receive this study infusion.

Eligibility

Patient should be less than or equal to 18 years of age;
Patient has a suitable adult family member donor available for NK cell donation
Patient not pregnant and not lactating are eligible for the study
Patient has relapsed or refractory B-lineage ALL not in remission

For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).

Contact

David Shook, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-866-2ST-JUDE (1-866-278-5833)
FAX: 901-595-5068

Referring or consulting physicians only: protocolinfo@stjude.org

For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.

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