Registry of Patients Having Received oNKord®

Sponsor

Glycostem Therapeutics BV (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05290662

Collaborator

(none)

Enrollment

Locations

68.6

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AML	Drug: oNKord® Drug: Cyclophosphamide/Fludarabine (Cy/Flu)

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 14, 2022

Anticipated Primary Completion Date :

Mar 1, 2028

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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 disease status [3 years]
Long-term follow-up on cancer-related treatments [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medizinische Hochschule Hannover	Hannover		Germany
2	University Hospital Basel	Basel		Switzerland

Sponsors and Collaborators

Glycostem Therapeutics BV

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Glycostem Therapeutics BV

ClinicalTrials.gov Identifier:

NCT05290662

Other Study ID Numbers:

ReKORD

First Posted:

Mar 22, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Jun 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Glycostem Therapeutics BV

Additional relevant MeSH terms:

Cyclophosphamide

Fludarabine

Study Results

No Results Posted as of Aug 4, 2022