This study will find the highest acceptable treatment dose and timing of infusion of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with multiple myeloma. The NK cells will be given at varying days post autologous stem cell transplant. rhIL-2 is administered after treatment to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating multiple myeloma.
The primary objective of the study is to assess safety and determine the maximum tolerated dose of PNK-007 as well as the feasibility of treating at various timepoints following ASCT in subjects with multiple myeloma. The secondary objective is to explore the potential clinical efficacy by day 90-100 post ASCT. Treatment plan includes ASCT followed by PNK-007 which will be administered IV Day 14 post ASCT to determine the maximum tolerated dose. Once the IV Day 14 post ASCT. PNK-007 will be followed by up to six rhIL-2 injections to support the NK cells expansion in the body. Subjects will be followed for up to 12 months post PNK-007.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
University of Minnesota
Minneapolis, Minnesota, United States
Washington Univ School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Mt. Sinai School of Medicine
New York, New York, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Dose-Limiting Toxicity (DLT)
Number and severity of adverse events within 28 days of administration
Time frame: Up to 28 days
Maximum Tolerated Dose (MTD)
The maximum dose safely administered for the treatment of patients with multiple myeloma
Time frame: Up to 28 days
Dose Timing After Autologous Stem Cell Transplant
The optimal dose timing safely administered for the treatment of patients with multiple myeloma post ASCT
Time frame: Up to 28 days
Adverse Events (AEs)
Number and severity of adverse events within 12 months of administration
Time frame: Up to 12 months
Response Rate
Clinical efficacy at day 90-100 post ASCT per International Myeloma Working Group criteria, including minimal residual disease
Time frame: Up to day 100
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