WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.
WiNK is a prospective 2-stage, open-label, single arm, multicenter Phase I/IIa trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission (CR) with residual measurable disease (MRD) and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Following informed consent and eligibility procedures, subjects enrolled in the trial will receive a lymphodepleting conditioning regimen consisting of cyclophosphamide and fludarabine (Cy/Flu) followed by up to 3 oNKord® infusions 4 days apart. Stage A of the trial (dose escalation stage) is designed to assess the safety and tolerability of up to 3 oNKord® infusions, 4 days apart, in 3 cohorts of 3 subjects, and to determine the oNKord® recommended Phase II dose (RP2D) to be used in Stage B. Stage B of the trial (expansion stage) will evaluate the safety, tolerability and efficacy of oNKord® at the RP2D in 24 subjects. All subjects treated with oNKord® will be followed up until 12 months after the start of treatment. Eligibility criteria for participation in the trial and follow-up duration are the same for subjects in both Stage A and Stage B.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Lymphodepleting conditioning regimen
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
University Hospital Ghent
Ghent, Belgium
RECRUITINGUniversity Hospital Leuven
Leuven, Belgium
RECRUITINGInstitut Gustave Roussy
Villejuif, France
Safety and tolerability of oNKord® using the cumulative incidence of the adverse events of special interest (AESI)
AESI include: Grade 3 to 4 infusion-related toxicity of oNKord®, as rated by CTCAE v5.0; Acute GVHD grade III and IV; CRS and ICANS ≥ Grade 2, as rated by the ASTCT Consensus Grading
Time frame: Up to 12 months
Efficacy of oNKord® using the cumulative incidence of MRD response as assessed by centralized assessment in bone marrow
Subjects with responses are defined as MRD negative subjects still in morphologic CR at any time during the follow-up period of the trial after receiving oNKord® at RP2D
Time frame: Up to 12 months
Safety and tolerability of the overall trial treatment (Cy/Flu in combination with up to three oNKord® infusions) using the cumulative incidence of AESI
AESI include: Grade 3 to 4 infusion-related toxicity of oNKord® as rated by CTCAE v5.0; Acute GVHD grade III and IV; CRS and ICANS ≥ Grade 2 as rated by the ASTCT Consensus Grading; Hemorrhagic cystitis; Death related to the overall trial treatment; Incidence and severity of viral, fungal, and bacterial infections with onset during the first two months following conditioning initiation, including viral reactivations, and infection related mortality defined as death due to infectious disease
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on event-free survival (EFS)
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on cumulative incidence of relapse (CIR)
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on the duration of MRD response
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Hospital Carl Gustav Carus Dresden
Dresden, Germany
RECRUITINGUniversity Medical Center Hamburg-Eppendorf
Hamburg, Germany
RECRUITINGHannover Medical School
Hanover, Germany
RECRUITINGUniversity Hospital Mainz
Mainz, Germany
RECRUITINGAmsterdam UMC
Amsterdam, Netherlands
RECRUITINGUniversity Hospital Basel
Basel, Switzerland
RECRUITINGUniversity Hospital Zürich
Zurich, Switzerland
RECRUITINGTime frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on overall survival (OS)
Time frame: Up to 12 months
Changes in Quality of Life (EORT QLQ-C30)
Time frame: Up to 12 months
Changes in Quality of Life (SF-36)
Time frame: Up to 12 months