Clinical Trials Logo
  1. Home
  2. Leukemia
  3. NCT01035216

A Phase I Study of GNKG168 in Patient With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL)

Leukemia Clinical Trial

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)

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01035216
Study type Interventional
Source SBI Biotech Co., Ltd.
Contact
Status Terminated
Phase Phase 1
Start date September 2009
Completion date November 2013
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05691608 - MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2 N/A
Recruiting NCT04092803 - Virtual Reality as a Distraction Technique for Performing Lumbar Punctures in Children and Young Adu N/A
Active, not recruiting NCT02530463 - Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome Phase 2
Completed NCT00948064 - Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS) Phase 2
Completed NCT04474678 - Quality Improvement Project - "My Logbook! - I Know my Way Around!"; ("Mein Logbuch - Ich Kenne Mich Aus!") N/A
Terminated NCT00801931 - Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders Phase 1/Phase 2
Recruiting NCT03948529 - RevErsing Poor GrAft Function With eLtrombopag After allogeneIc Hematopoietic Cell trAnsplantation Phase 2
Completed NCT01682226 - Cord Blood With T-Cell Depleted Haplo-identical Peripheral Blood Stem Cell Transplantation for Hematological Malignancies Phase 2
Completed NCT00003270 - Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic Cancer Phase 2
Active, not recruiting NCT02723994 - A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia Phase 2
Terminated NCT02469415 - Pacritinib for Patients With Lower-Risk Myelodysplastic Syndromes (MDS) Phase 2
Recruiting NCT04856215 - 90Y-labelled Anti-CD66 ab in Childhood High Risk Leukaemia Phase 2
Recruiting NCT06155188 - Post-transplant PT/FLU+CY Promotes Unrelated Cord Blood Engraftment in Haplo-cord Setting in Childhood Leukemia N/A
Completed NCT00001637 - Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults Phase 2
Active, not recruiting NCT04188678 - Resiliency in Older Adults Undergoing Bone Marrow Transplant N/A
Completed NCT02910583 - Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) Phase 2
Completed NCT01212926 - Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain N/A
Terminated NCT00014560 - Antibody Therapy in Treating Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia Phase 1
Recruiting NCT04977024 - SARS-CoV-2 Vaccine (GEO-CM04S1) Versus mRNA SARS-COV-2 Vaccine in Patients With Blood Cancer Phase 2
Recruiting NCT05866887 - Insomnia Prevention in Children With Acute Lymphoblastic Leukemia N/A