NKR-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).
Conditions
Interventions
Product Name: NKR-2
Product Code: NKR-2
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Not available
CAS Number: Not applicab
Current Sponsor code: NKR-2/DS
Other desc
Sponsors
Celyad Onclogy SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to document and characterized: Phase I: the safety of the NKR-2 treatment administration in r/r AML/MDS patients after a non-myeloablative preconditioning. Phase II: the clinical activity of the NKR-2 treatment administration in r/r AML/MDS patients after a non-myeloablative preconditionning;Secondary Objective: The secondary objectives are to document and characterize: • The NKR-2 peripheral blood kinetics post-administration, • Indicators of clinical activity, • Additional indicators of safety. ;Primary end point(s): Phase I: The occurrence of DLTs during the study treatment. Phase II: The objective response rate (ORR) post the first KKR-2 administration;Timepoint(s) of evaluation of this end point: Phase I: During the administration phase, up to administration phase concluding visit. Phase II: at W3, W7 (only if consolidation cycle), W11, and only for patients authorized for the consolidation cycle at M6, M9, M12, M18 and M24 post the first NKR-2 administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PHASE I A - NKR-2 cell kinetics and dynamics endpoints 1) The evaluation of circulating NKR-2 in the peripheral blood and its kinetics post-injection. B - Safety endpoints 2) The occurrence of AEs and SAEs and any toxicity linked to study participation until the end of the treatment follow-up (at M24). C - Clinical activity endpoints 3) The overall survival (OS), relapse-free survival (RFS) and event-free survival (EFS) from study enrollment. 4) The objective clinical response rate (ORR) and objective clinical benefit rate (OCBR) post the first NKR-2 administration. 5) The duration of response for patients with objective clinical response 6) The ORR and duration of second response among patients retreated with NKR-2. 7) The cumulative incidence of relapse (CIR) and cumulative incidence of death (CID). 8) The non-relapse mortality (NMR) rate. 9) For AML patients: the incidence of CR, CRMRD-, CRi, MLFS, PR, or SD post NKR-2 administrations until the end of the treatment follow-up (at M24). 10) For MDS patients: the incidence of CR, PR, marrow CR, cytogenic response, hematologic improvement or SD post NKR-2 administrations until the end of the treatment follow-up (at M24). Phase II: A - Safety endpoints 1) The occurrence of DLTs during the administration phase, 2) The occurrence of AEs and SAEs and any toxicity linked to study participation until the end of the treatment follow-up (at M24). B - Clinical activity endpoints 3) The overall survival (OS), relapse-free survival (RFS) and event-free survival (EFS) from study enrollment. 4) The objective clinical benefit rate (OCBR) post the first NKR-2 administration. 5) The duration of response for patients with objective clinical response. 6) The ORR and duration of second response among patients retreated with NKR-2. 7) The cumulative incidence of relapse (CIR) and cumulative incidence of death (CID). 8) The non-relapse mortality (NMR) rate. 9) For AML patients: the incidence of CR, CRMRD-, CR | — |
Countries
Belgium, United States
Contacts
Public ContactClinical Trial Information
Celyad Oncology SA
Outcome results
None listed