MedTrace Logo

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

NCT04632316 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2022-06-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Glycostem Therapeutics BV

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Arnold Ganser, MD · Hannover Medical School (MHH), Hannover, Germany

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2023-04-30
Completion
2023-04-30

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04632316 on ClinicalTrials.gov