NCT04632316

Brief Summary

WiNK is a Phase I/IIa trial to evaluate the safety and efficacy of oNKord® in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission with residual measurable disease and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2020

Typical duration for phase_1

Geographic Reach
5 countries

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

2.3 years

First QC Date

November 2, 2020

Last Update Submit

June 15, 2022

Conditions

Acute Myeloid Leukemia

Keywords

AMLNK cellsUmbilical cord bloodoNKordATMPOff the shelfCell therapyImmunotherapyOncologyLeukemiaBlood cancer

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability of oNKord® using the cumulative incidence of the adverse events of special interest (AESI)

    AESI include: Grade 3 to 4 infusion-related toxicity of oNKord®, as rated by CTCAE v5.0; Acute GVHD grade III and IV; CRS and ICANS ≥ Grade 2, as rated by the ASTCT Consensus Grading

    Up to 12 months

  • Efficacy of oNKord® using the cumulative incidence of MRD response as assessed by centralized assessment in bone marrow

    Subjects with responses are defined as MRD negative subjects still in morphologic CR at any time during the follow-up period of the trial after receiving oNKord® at RP2D

    Up to 12 months

Secondary Outcomes (7)

  • Safety and tolerability of the overall trial treatment (Cy/Flu in combination with up to three oNKord® infusions) using the cumulative incidence of AESI

    Up to 12 months

  • Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on event-free survival (EFS)

    Up to 12 months

  • Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on cumulative incidence of relapse (CIR)

    Up to 12 months

  • Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on the duration of MRD response

    Up to 12 months

  • Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on overall survival (OS)

    Up to 12 months

  • +2 more secondary outcomes

Study Arms (1)

oNKord®

EXPERIMENTAL

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

Drug: Cyclophosphamide-Fludarabine (Cy/Flu)Drug: oNKord®

Interventions

Cyclophosphamide-Fludarabine (Cy/Flu)DRUG

Lymphodepleting conditioning regimen

oNKord®
oNKord®DRUG

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

oNKord®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female subjects ≥ 18 years old
  • Subjects with a diagnosis of AML and related precursor neoplasms according to the WHO 2016 classification (excluding acute promyelocytic leukemia), including secondary AML after an antecedent hematological disease (e.g. myelodysplastic syndrome) and therapy-related AML
  • Subjects who have achieved morphologic CR, including CRi and complete clinical remission, with MRD documented at screening, as assessed by centralized MFC, after one or two courses of remission induction chemotherapy and who have completed consolidation chemotherapy or who achieved morphologic CR with documented MRD with hypomethylating agents or other relevant appropriate therapies
  • Subjects who are currently (at the time of screening) not proceeding to allo-HSCT
  • Life expectancy ≥ 6 months at screening
  • Adequate renal and hepatic functions within 14 days of study screening, unless clearly disease related, as indicated by the following laboratory values:
  • Serum creatinine ≤ 3 times the upper limit of normal (ULN) and estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m2
  • Serum total bilirubin \< 2.0 mg/dl, unless due to Gilbert's syndrome
  • Alanine transaminase (ALT) ≤ 2.5 x ULN
  • Karnofsky Status ≥ 50%
  • Seropositivity for EBV
  • Male subjects with partners who are women of childbearing potential must use an effective contraceptive method during the trial and for a minimum of 6 months after trial treatment, or have undergone successful vasectomy at least 6 months prior to entry into the trial (confirmed by semen analysis).
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening and agree to use an effective contraceptive method during the trial and for a minimum of 6 months after trial treatment.
  • Able to understand and willing to provide written informed consent to participate in the trial
  • Affiliation to a national health insurance scheme (according to applicable local requirements)

You may not qualify if:

  • Subjects having received prior allogeneic HSCT
  • Subjects with acute promyelocytic leukemia
  • Blast crisis of chronic myeloid leukemia
  • Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, uncontrolled hypertension, active or uncontrolled infection) including abnormal laboratory values, that could compromise compliance with the trial protocol or cause unacceptable safety risks
  • Known allergy to any of the components of oNKord® (e.g., dimethyl sulfoxide \[DMSO\]) or to any of the drugs to be administered in the preparative regimen to oNKord® infusion
  • Contraindication to any of the drugs to be administered in the conditioning regimen or oNKord® infusion. This includes Cy, Flu, and medications associated with prophylaxis of AEs
  • Cardiac dysfunction as defined by:
  • Myocardial infarction within the last 3 months of trial entry, or
  • Reduced left ventricular function with an ejection fraction \< 40% as measured by multi-gated acquisition (MUGA) scan or echocardiogram (echo) within 28 days before screening, or
  • Unstable angina, or
  • New York Heart Association (NYHA) Class IV congestive heart failure, or
  • Unstable cardiac arrhythmias
  • Pulmonary dysfunction as defined by oxygen saturation \< 90% on room air. Pulmonary function test (PFT) is required only in the case of symptomatic or prior known impairments within 28 days before screening - with pulmonary function \< 50% corrected diffusing capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1)
  • Major surgery within 4 weeks prior to screening or a major wound that has not fully healed
  • Vaccination with live, attenuated vaccines within 4 weeks prior to screening
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital Ghent

Ghent, Belgium

RECRUITING

University Hospital Leuven

Leuven, Belgium

RECRUITING

Institut Gustave Roussy

Villejuif, France

NOT YET RECRUITING

University Hospital Carl Gustav Carus Dresden

Dresden, Germany

RECRUITING

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

Hannover Medical School

Hanover, Germany

RECRUITING

University Hospital Mainz

Mainz, Germany

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

University Hospital Basel

Basel, Switzerland

RECRUITING

University Hospital Zürich

Zurich, Switzerland

RECRUITING

Related Publications (1)

  • Raimo M, Zavoianu AG, Meijs W, Scholten P, Spanholtz J. Qualification of a flow cytometry-based method for the evaluation of in vitro cytotoxicity of GTA002 natural killer cell therapy. Heliyon. 2024 Jan 17;10(2):e24715. doi: 10.1016/j.heliyon.2024.e24715. eCollection 2024 Jan 30.

    PMID: 38304826DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteNeoplasmsLeukemiaHematologic Neoplasms

Interventions

CF regimen

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Site

Study Officials

  • Prof. Dr. Arnold Ganser, MD

    Hannover Medical School (MHH), Hannover, Germany

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kai Pinkernell, MD

CONTACT

+31(0) 412 211 001medical@glycostem.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2020

First Posted

November 17, 2020

Study Start

December 8, 2020

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)NL(1)CH(2)BE(2)DE(4)