Registry of Patients Having Received oNKord®

Glycostem Therapeutics

Status: Enrolling

Conditions: AML

Treatments: Drug: oNKord®; Drug: Cyclophosphamide/Fludarabine (Cy/Flu)

Study type: Observational

Funder types: Industry

Identifiers

NCT05290662

ReKORD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Participants having received oNKord® as part of the WiNK clinical trial

Description:

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

Treatment:

Drug: Cyclophosphamide/Fludarabine (Cy/Flu)

Drug: oNKord®