A Phase 1 interventional study of rhIL-2 and PNK-007 in Multiple Myeloma, sponsored by Celularity Incorporated. Completed at 7 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-22.
Sponsored by Celularity Incorporated · Phase 1, Interventional, and Treatment
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 15 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Celularity Incorporated is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects must satisfy the following criteria to be enrolled in the study:
Subject has eligible disease status:
Female of childbearing potential (FCBP) must:
Either commit to true abstinence* from heterosexual contact (which must be reviewed at applicable study visits and source documented) or agree to use, and be able to comply with, effective contraception without interruption, during the study therapy (including dose interruptions), and for 28 days after discontinuation of PNK-007.
A female of childbearing potential (FCBP) is a female who:
Male subjects must:
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
Subject has history of malignancy, other than multiple myeloma (MM), unless the subject has been free of disease for > 3 years from the date of signing the ICF. Exceptions include the following:
Melphalan per institutional practices (within Day -5 to 01), ASCT (Day 0), PNK-007 at varying dose levels (within Day 7 to Day 14) and rhIL-2 every other day starting day of PNK-007 administration.
Drug: rhIL-2 · Biological: PNK-007
Human recombinant Interleukin-2
PNK-007 is a culture-expanded cell population derived from human cord blood hematopoietic stem/progenitor cells.
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
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Celularity Incorporated