oNKord® is an off-the-shelf cryopreserved allogeneic NK cell preparation for intravenous infusion currently in development for the treatment of hematologic malignancies and solid tumors. A phase I/IIa study of oNKord® for the treatment of acute myeloid leukemia was initiated in November 2020.
Patients and healthcare professionals that are interested and would like to receive information upfront can contact us.
Ongoing clinical trial
Glycostem initiated a phase I/IIa (pivotal) trial to evaluate the safety and efficacy of oNKord® in patients with Acute Myeloid Leukemia (AML) in November 2020. The WiNK trial will enrol 33 AML patients at eight clinical sites based in five European countries.
Therapy |
Indication |
Trial name |
|
|---|---|---|---|
oNKord® |
Acute myeloid leukemia |
A Trial to Evaluate the Safety and Efficacy of oNKord® in Subjects With Acute Myeloid Leukemia . |
Completed clinical trials
Results of the AML oNKord® safety study is the baseline for application of oNKord® for all indications.
Therapy |
Indication |
Trial number |
Trial name |
|---|---|---|---|
oNKord® |
Acute myeloid leukemia |
oNKord® - Acute Myeloid Leukemia – phase I
In collaboration with the Department of Hematology of the Radboud Medical Centre in Nijmegen (The Netherlands) a first in man study has been conducted using oNKord®. This HOVON-associated study was designed for elderly acute myeloid leukemia (AML) patients who were not eligible for allogeneic stem cell transplantation. Patients who had successfully achieved complete remission after chemotherapy were treated with oNKord®.
- Ten elderly AML patients ineligible to receive allogeneic stem-cell transplantation (Allo-SCT) were treated with oNKord® following chemotherapy and fludarabine cyclophosphamide (Flu- Cy) conditioning
- Confirmed that 100 billion NK cells can be produced from one cord blood under GMP
- Demonstrated no T-cell impurity
- No dose limiting toxicities or Graft-versus-Host Disease (GVHD) observed in the study
- oNKord® cells show in vivo survival, expansion and further maturation
- oNKord® cells home to the bone marrow and target leukemia cells
- Treatment with oNKord® resulted in strong reduction of residual disease as well as prolonged Progression-free Survival and Overall Survival as compared to historical data.
