Registry of Patients Having Received oNKord®

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05290662
• Other study ID #: ReKORD
• Status: Recruiting
• Start date: June 14, 2022
• Est. completion date: March 2028

Study information

• Verified date: June 2022
• Source: Glycostem Therapeutics BV
• Contact: Katarzyna Nowek, PhD
• Phone: +31(0)412211001
• Email: medical[@]glycostem.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Receipt of at least one dose of oNKord® in a clinical trial

• Participation must be within 3 years after the first infusion of oNKord®

• Signature of ICF

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• AML

Intervention

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

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Glycostem Therapeutics BV

Countries where clinical trial is conducted

Germany,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SAEs related to oNKord® over time	Safety	3 years
Primary	Incidence of SAEs related to Cyclophosphamide-Fludarabine over time	Safety	3 years
Primary	Long-term follow-up on survival		3 years
Primary	Long-term follow-up on disease status		3 years
Primary	Long-term follow-up on cancer-related treatments		3 years