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NCT Number: NCT05290662

Registry of Patients Having Received oNKord®

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.

Recruiting

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Key information

Conditions

AML

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Hochschule Hannover, Hanover, Germany

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oNKord®

Drug

Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells

Cyclophosphamide/Fludarabine (Cy/Flu)

Drug

Lymphodepleting conditioning regimen

Primary outcomes

  1. Incidence of SAEs related to oNKord® over time

    Time frame: 3 years

    Safety

  2. Incidence of SAEs related to Cyclophosphamide-Fludarabine over time

    Time frame: 3 years

    Safety

  3. Long-term follow-up on survival

    Time frame: 3 years

  4. Long-term follow-up on disease status

    Time frame: 3 years

  5. Long-term follow-up on cancer-related treatments

    Time frame: 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Katarzyna Nowek, PhD

CONTACT

[email protected]

+31(0)412211001

Sponsors and collaborators

Lead sponsor

Glycostem Therapeutics BV

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 22, 2022
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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