NCT05290662

Registry of Patients Having Received oNKord®

A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have Received oNKord®

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Glycostem Therapeutics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

ReKORD is an observational study (Registry) enrolling participants who have received at least one dose of oNKord® (allogeneic ex vivo-generated Natural Killer \[NK\] cells from CD34+ umbilical cord blood progenitor cells) in a clinical trial. Participants from multiple previous clinical trials of oNKord® can be enrolled in this Registry.

Detailed description

To be eligible for this Registry, participants must have received at least one dose of oNKord® in a clinical trial. Eligible participants will be enrolled after signing the informed consent form (ICF). Participant characteristics, treatment history, and clinical trial outcome data at clinical trial discontinuation/completion will be collected. On a yearly basis after the last clinical trial visit, the investigator will collect the participants' medical status and enter them in the Registry database. Major clinical events, including concomitant medication or therapy, that occurred since the previous assessment will be recorded. No protocol-specific visits or interventions will be required. Participants will be followed up until 3 years after the first oNKord® infusion.

Conditions

• AML

Interventions

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

Timeline

• Start date: 2022-06-14
• Primary completion: 2028-03-01
• Completion: 2028-03-01
• First posted: 2022-03-22
• Last updated: 2022-08-04

Locations

2 sites across 2 countries: Germany, Switzerland