Registry of Patients Having Received oNKord®

Recruiting

• Conditions: AML
• Interventions: Drug: oNKord®; Drug: Cyclophosphamide/Fludarabine (Cy/Flu)

• Registration Number: NCT05290662
• Lead Sponsor: Glycostem Therapeutics BV

Brief 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.

Study Timeline

• Study First Submitted: 2022-03-02
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-22
• Status Verified: 2022-06
• Study Start: 2022-06-14
• Last Update Submitted: 2022-08-03
• Last Update Posted: 2022-08-04
• Primary Completion: 2028-03
• Study Completion: 2028-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants having received oNKord® as part of the WiNK clinical trial	oNKord®	WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and not currently proceeding to hematopoietic stem cell transplantation
Participants having received oNKord® as part of the WiNK clinical trial	Cyclophosphamide/Fludarabine (Cy/Flu)	WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and not currently proceeding to hematopoietic stem cell transplantation

Primary Outcome Measures

Name	Time	Method
Long-term follow-up on disease status	3 years
Incidence of SAEs related to oNKord® over time	3 years	Safety
Incidence of SAEs related to Cyclophosphamide-Fludarabine over time	3 years	Safety
Long-term follow-up on survival	3 years
Long-term follow-up on cancer-related treatments	3 years

Trial Locations

Locations (2)

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

University Hospital Basel; 🇨🇭 Basel, Switzerland