A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of GNKG168 Administered by Intravenous Infusion in Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)|
- To determine the dose limiting toxicity (DLT) and recommended phase 2 dose
|Study Start Date:||September 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
The starting dose will be 0.25 mg/kg. If the dose is tolerable, subsequent cohorts will be enrolled and treated with 0.5, 0.75, 1.0 and 1.5 mg/kg. If 0.25 mg/kg proves to be intolerable, the dose will be reduced to 0.15 mg/kg.
GNKG168 will be administered as a 60 minute IV infusion once daily for 5 days followed by a 9 day rest period.
Other Name: CpG ODN
This is an open-label, dose escalation study designed to characterize the safety, tolerability, efficacy, and pharmacokinetics of GNKG168 in patients with B-CLL that has relapsed or is refractory to all prior standard therapy, or for which no standard therapy exists.
As secondary objectives, baseline TLR-9 intracellular staining of B-CLL cells, and in vitro assays to assess the potential of B-CLL cells to undergo apoptosis in conjunction with GNKG168 therapy will be examined. Baseline characteristics of B-CLL will be examined including interphase genetics, FISH CLL, IgVH mutational status, expression of ZAP70, β2-microglobulin and the expression of the prognostic marker CD38 in peripheral blood cells (at baseline and during treatment) and baseline immune SNPs (FcγRIIIa, FcγRIIa, TNF-α, IFN-γ, CD40 and others). As pharmacodynamics parameters, the expression of B-cell and T-cell activation markers (including IL-21 receptor upregulation), NK cell markers, and cytokines will be investigated.
This clinical trial will also assess the ability of B CLL patients treated with GNKG168 to elicit anti pneumococcal antibodies in response to adjuvant vaccination with the Prevnar™ vaccine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01035216
|United States, California|
|Univ. of San Diego: Moores UCSD Cancer Center|
|La Jolla, California, United States, 92093|
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|North Shore University Hospital|
|New Hyde Park, New York, United States, 11042|
|New York, New York, United States, 10021|
|United States, Oregon|
|Oregon Health & Sciences University|
|Portland, Oregon, United States, 97239|