Research study aiming at investigating the potential safety of multiple administrations of NKR-2 after chemotherapy treatment targeting T-cells in patients with acute myeloid leukemia. The NKR-2 treatment is based on patient's own T-cells that will be collected and modified before being injected to generate anti-tumor responses.
- Conditions
- KR-2 has the potential to treat many distinct tumor-types. This trial will focus on Relapsed and/or refractory (r/r) acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000205-22-BE
- Lead Sponsor
- Celyad Onclogy SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 17
1) Men or women = 18 and = 75 years old at the time of signing the Informed Consent Form (ICF).
2) The patient is not eligible for standard of care therapy and must have one of the following hematological malignancy:
- A confirmed relapsed or refractory acute myeloid leukemia (AML) (i.e. = 5% blasts in bone marrow or in peripheral blood) after at least one prior therapy.
- A confirmed myelodysplastic syndrome (MDS) with revised International Prognostic Scoring System (R-IPSS) criteria for Intermediate, High-risk or Very High-risk disease or refractory anemia with excess blasts by WHO (i.e. = 5% blasts in bone marrow or = 2% blasts in peripheral blood) or MDS with TP53 mutation as detected by next-generation sequencing (NGS).
3) The absolute peripheral blast count should be < 15,000/µL.
4) The patient must have an ECOG performance status =2.
5) The patient must have sufficient hepatic and renal functions,.
6) Ejection fraction of = 40%.
7)Patients must have sufficient pulmonary functions with a Forced Expiratory Volume in the first second (FEV-1)/Forced Vital Capacity (FVC) = 0.7 with FEV-1 = 50% predicted.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1) Patient presenting with history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis and/or active or acute exacerbation of chronic obstructive pulmonary disease (COPD).
2) Patient that received any cancer therapy within 2 weeks before the planned day for the apheresis (with the exception of hydroxyurea).
3) Patients receive, concurrently receive, or have received any investigational agent within 3 weeks before the planned day for the first NKR-2 administration (except for hydroxyurea).
4) Patient is under systemic immunosuppressive drugs, unless specific cases authorized per protocol.
5) Patients have received prior allogeneic stem cell transplantation or chimeric antigen receptor therapy.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method