Registry of Patients Having Received oNKord®

August 3, 2022 updated by: Glycostem Therapeutics BV

A Prospective Multicenter Observational Study to Assess Long-term Outcome of Participants Who Have 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Hannover, Germany
        • Recruiting
        • Medizinische Hochschule Hannover
        • Contact:
          • Prof. Dr. Michael Heuser, MD
  • Switzerland
      • Basel, Switzerland
        • Recruiting
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants who have received at least one dose of oNKord® in a clinical trial and are within 3 years of follow-up after the first infusion, and who have provided informed consent for participation in this Registry.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glycostem Therapeutics BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 14, 2022

Primary Completion (ANTICIPATED)

March 1, 2028

Study Completion (ANTICIPATED)

March 1, 2028

Study Registration Dates

First Submitted

March 2, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (ACTUAL)

March 22, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ReKORD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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