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.
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 Type
OBSERVATIONAL
Enrollment
50
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
Lymphodepleting conditioning regimen
Medizinische Hochschule Hannover
Hanover, Germany
RECRUITINGUniversity Hospital Basel
Basel, Switzerland
RECRUITINGIncidence of SAEs related to oNKord® over time
Safety
Time frame: 3 years
Incidence of SAEs related to Cyclophosphamide-Fludarabine over time
Safety
Time frame: 3 years
Long-term follow-up on survival
Time frame: 3 years
Long-term follow-up on disease status
Time frame: 3 years
Long-term follow-up on cancer-related treatments
Time frame: 3 years
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