MDS with excess blasts, MDS/AML or AML patients
Conditions
Brief summary
During the phase I safety study, patients will be evaluated intensively for toxicity caused by the RNK001 NK cell infusions, whether or not followed by SC IL-2, using the CTCAE toxicity criteria and graft versus host disease (GvHD) classification criteria, defining dose limiting toxicities (DLTs). For phase IIa of the study, clinical response to therapy is the main study parameter and will be defined according to European Leukemia Network (ELN) response criteria by day +28 post NK cell adminis.
Interventions
Sponsors
Stichting Radboud universitair medisch centrum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| During the phase I safety study, patients will be evaluated intensively for toxicity caused by the RNK001 NK cell infusions, whether or not followed by SC IL-2, using the CTCAE toxicity criteria and graft versus host disease (GvHD) classification criteria, defining dose limiting toxicities (DLTs). For phase IIa of the study, clinical response to therapy is the main study parameter and will be defined according to European Leukemia Network (ELN) response criteria by day +28 post NK cell adminis. | — |
Countries
Netherlands
Outcome results
None listed