NCT04632316

A Trial to Evaluate the Safety and Efficacy of oNKord® in Subjects With Acute Myeloid Leukemia

A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission With Measurable Residual Disease and Who Are Currently Not Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Glycostem Therapeutics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
DRUG	Cyclophosphamide-Fludarabine (Cy/Flu)	Lymphodepleting conditioning regimen
DRUG	oNKord®	Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells

Timeline

• Start date: 2020-12-08
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-11-17
• Last updated: 2022-06-21

Locations

10 sites across 5 countries: Belgium, France, Germany, Netherlands, Switzerland