Acute Myeloid LeukemiaPhase 1/2NCT04632316
A Trial to Evaluate the Safety and Efficacy of oNKord® in Subjects With Acute Myeloid Leukemia
A Phase 1/2 study testing Cyclophosphamide-Fludarabine (Cy/Flu) and oNKord® in people with Acute Myeloid Leukemia, run by Glycostem Therapeutics BV at 10 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Cyclophosphamide-Fludarabine (Cy/Flu) and oNKord®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 10 sitesin 5 countries
- Study dates
- 8 Dec 2020to Apr 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- Subjects having received prior allogeneic HSCT
- Subjects with acute promyelocytic leukemia
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion, except when the subject completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to enrolment
- 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
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- 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
- Immunosuppressive drugs for concomitant disease. Subject must be able to be off prednisone or other immunosuppressive medications for at least 3 days prior to the start of Cy/Flu regimen
- History of stroke or intracranial hemorrhage within 6 months prior to screening
- Active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to trial treatment
- History of human immunodeficiency virus (HIV) or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
- Subjects who are undergoing or will be undergoing chemotherapy (including HMAs), radiation therapy, targeted therapy or immunotherapy that cannot be finished or stopped at least 1 week prior to initiating the Cy/Flu conditioning regimen
- Positive pregnancy test or breastfeeding for women of childbearing potential
- Use of other investigational drugs/therapies within 3 weeks prior to trial treatment (within 6 weeks in the case of drugs/therapies with long half-life) or participation in a concomitant interventional clinical trial
- Any serious concomitant medical condition, medication or therapy which could, in the opinion of the Investigator, compromise participation in the trial
- Subjects under legal protection measure (guardianship, trusteeship or safeguard of justice) and/or inability or unwillingness to comply with the requirements and procedures of this trial
Trial locations and contacts
10 sites in 5 countries.
10 sites in 5 countries
Germany4 sites, 4 recruiting
- Recruiting
University Hospital Carl Gustav Carus Dresden
Dresden
- Recruiting
University Medical Center Hamburg-Eppendorf
Hamburg
- Recruiting
Hannover Medical School
Hanover
- Recruiting
University Hospital Mainz
Mainz
Belgium2 sites, 2 recruiting
- Recruiting
University Hospital Ghent
Ghent
- Recruiting
University Hospital Leuven
Leuven
Switzerland2 sites, 2 recruiting
- Recruiting
University Hospital Basel
Basel
- Recruiting
University Hospital Zürich
Zurich
About this study
Official title: A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission With Measurable Residual Disease and Who Are Currently Not Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation
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.
Read the detailed description
WiNK is a prospective 2-stage, open-label, single arm, multicenter Phase I/IIa trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission (CR) with residual measurable disease (MRD) and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Following informed consent and eligibility procedures, subjects enrolled in the trial will receive a lymphodepleting conditioning regimen consisting of cyclophosphamide and fludarabine (Cy/Flu) followed by up to 3 oNKord® infusions 4 days apart.
Stage A of the trial (dose escalation stage) is designed to assess the safety and tolerability of up to 3 oNKord® infusions, 4 days apart, in 3 cohorts of 3 subjects, and to determine the oNKord® recommended Phase II dose (RP2D) to be used in Stage B.
Stage B of the trial (expansion stage) will evaluate the safety, tolerability and efficacy of oNKord® at the RP2D in 24 subjects.
All subjects treated with oNKord® will be followed up until 12 months after the start of treatment. Eligibility criteria for participation in the trial and follow-up duration are the same for subjects in both Stage A and Stage B.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Cyclophosphamide-Fludarabine (Cy/Flu), oNKord®
- Keywords
- AML, NK cells, Umbilical cord blood, oNKord, ATMP, Off the shelf, Cell therapy, Immunotherapy, Oncology, Leukemia, Blood cancer
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasms, Leukemia, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclophosphamide-Fludarabine (Cy/Flu)Drug
Lymphodepleting conditioning regimen
oNKord®Drug
Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
| Study group | Role | What they receive |
|---|---|---|
| oNKord® | Experimental | Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells Receives: Drug: Cyclophosphamide-Fludarabine (Cy/Flu); Drug: oNKord® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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; Hemorrhagic cystitis; Death related to the overall trial treatment; Incidence and severity of viral, fungal, and bacterial infections with onset during the first two months following conditioning initiation, including viral reactivations, and infection related mortality defined as death due to infectious disease
Measured: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on event-free survival (EFS)
Measured: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on cumulative incidence of relapse (CIR)
Measured: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on the duration of MRD response
Measured: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on overall survival (OS)
Measured: Up to 12 months
Changes in Quality of Life (EORT QLQ-C30)
Measured: Up to 12 months
Changes in Quality of Life (SF-36)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start8 Dec 2020
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glycostem Therapeutics BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Prof. Dr. Arnold Ganser, MD, Principal investigator, Hannover Medical School (MHH), Hannover, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632316
- Sponsor's protocol ID
- WiNK
- Other IDs
- 2019-003686-17, 2019
- Status last verified
- Jun 2022
- First submitted
- 2 Nov 2020
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38304826
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase I/IIa, Open-label, Multicenter Trial to Evaluate the Safety and Efficacy of oNKord®, an Off-the-shelf, ex Vivo-cultured Allogeneic NK Cell Preparation, in Subjects With Acute Myeloid Leukemia Who Are in Morphologic Complete Remission With Measurable Residual Disease and Who Are Currently Not Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04632316
- Acronym / sponsor ID
- WiNK
- Conditions
- Acute Myeloid Leukemia
- Keywords
- AML, NK cells, Umbilical cord blood, oNKord, ATMP, Off the shelf, Cell therapy, Immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Glycostem Therapeutics BVIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
WiNK is a prospective 2-stage, open-label, single arm, multicenter Phase I/IIa trial to evaluate the safety and efficacy of oNKord®, an off-the-shelf, ex vivo-cultured allogeneic NK cell preparation, in 33 adults with acute myeloid leukemia (AML) who are in morphologic complete remission (CR) with residual measurable disease (MRD) and who are currently not proceeding to allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Following informed consent and eligibility procedures, subjects enrolled in the trial will receive a lymphodepleting conditioning regimen consisting of cyclophosphamide and fludarabine (Cy/Flu) followed by up to 3 oNKord® infusions 4 days apart.
Stage A of the trial (dose escalation stage) is designed to assess the safety and tolerability of up to 3 oNKord® infusions, 4 days apart, in 3 cohorts of 3 subjects, and to determine the oNKord® recommended Phase II dose (RP2D) to be used in Stage B.
Stage B of the trial (expansion stage) will evaluate the safety, tolerability and efficacy of oNKord® at the RP2D in 24 subjects.
All subjects treated with oNKord® will be followed up until 12 months after the start of treatment. Eligibility criteria for participation in the trial and follow-up duration are the same for subjects in both Stage A and Stage B.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oNKord® | Experimental | Drug: Cyclophosphamide-Fludarabine (Cy/Flu), Drug: oNKord®Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (25 listed)
- Subjects having received prior allogeneic HSCT
- Subjects with acute promyelocytic leukemia
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion, except when the subject completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 6 months prior to enrolment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyclophosphamide-Fludarabine (Cy/Flu)Lymphodepleting conditioning regimen | Drug | oNKord® |
| oNKord®Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells | Drug | oNKord® |
Primary outcome
Safety and tolerability of oNKord® using the cumulative incidence of the adverse events of special interest (AESI)
Time frame: Up to 12 months
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
Efficacy of oNKord® using the cumulative incidence of MRD response as assessed by centralized assessment in bone marrow
Time frame: Up to 12 months
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
7 secondary outcomes
Safety and tolerability of the overall trial treatment (Cy/Flu in combination with up to three oNKord® infusions) using the cumulative incidence of AESI
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on event-free survival (EFS)
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on cumulative incidence of relapse (CIR)
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on the duration of MRD response
Time frame: Up to 12 months
Efficacy of the overall trial treatment (Cy/Flu in combination with oNKord® at RP2D) on overall survival (OS)
Time frame: Up to 12 months
Changes in Quality of Life (EORT QLQ-C30)
Time frame: Up to 12 months
Changes in Quality of Life (SF-36)
Time frame: Up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Derived from this study: PubMed 38304826Raimo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Dr. Arnold Ganser, MD principal investigator
Hannover Medical School (MHH), Hannover, Germany
10 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyclophosphamide-Fludarabine (Cy/Flu) and oNKord® in people with Acute Myeloid Leukemia, run by Glycostem Therapeutics BV at 10 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Belgium, Switzerland, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Pinkernell, MD (+31(0) 412 211 001, medical@glycostem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of oNKord® using the cumulative incidence of the adverse events of special interest (AESI) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632316, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2022.