Registry of Patients Having Received oNKord®

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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AML

Intervention / Treatment
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* Drug: oNKord®
* Drug: Cyclophosphamide/Fludarabine (Cy/Flu)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants having received oNKord® as part of the WiNK clinical trial<br>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 | Drug: oNKord®<br>* Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells<br>Drug: Cyclophosphamide/Fludarabine (Cy/Flu)<br>* Lymphodepleting conditioning regimen<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NK cells, Umbilical cord blood, oNKord, Registry, Off the shelf