At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 47 enrolled

Drug / intervention

NK Cell infusion using CD56 monoclonal antibody +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00586690

NCT00586690Phase 1Completed

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Safety Trial of Natural Killer (NK) Cell Donor Lymphocyte Infusions(DLI) From 6/6 Human Leukocyte Antigen (HLA) Matched Family Member Following Nonmyeloablative Allogeneic Stem Cell Transplantation (ASCT)

David Rizzieri, MD·interventional·Posted Jan 4, 2008·Updated Feb 8, 2017

In Brief

A Phase 1 clinical trial evaluating NK Cell infusion using CD56 monoclonal antibody and Donor Apheresis for Lymphoma. Completed, enrolled 47 participants across 1 site.

Detailed Summary

Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation (SCT) from matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease and other severe toxicity.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsLymphoma

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2005

First PostedJan 2008

Primary CompletionMay 2013

Study CompletionNov 2013

TodayJul 2026

First PostedJan 4, 2008

Enrollment StartMay 1, 2005

Primary CompletionMay 1, 2013

Study CompletionNov 1, 2013

TodayJul 2, 2026

Enrollment to primary: 8 yearsPosted 18.5 years ago

Interventions

NK Cell infusion using CD56 monoclonal antibodydevice

The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.

Donor Apheresisprocedure

Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for \>24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.