NKR-2 has the potential to treat a number of distinct tumor-types (solid and hematological): colorectal cancer (CRC), epithelial ovarian and fallopian tube carcinoma, urothelial carcinoma, triple-negative breast cancer (TNBC), pancreatic cancer, acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS) and multiple myeloma (MM)
Conditions
Interventions
Product Name: NKR-2
Product Code: NKR-2
Pharmaceutical Form: Solution for infusion
Sponsors
Celyad SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria are: 1) Men or women = 18 years old at the time of signing the ICF, 2) Patient with a CRC, epithelial ovarian cell or fallopian tube carcinoma, urothelial carcinoma, TNBC, pancreatic cancer, AML/MDS or MM, 3) Disease must be measurable according to the corresponding guidelines, 4) Patient with an ECOG performance status 0 or 1, 5) Patient with adequate bone marrow reserve, hepatic and renal functions. 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 111 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: Main exclusion criteria are: 1) Patient with a tumor metastasis in the central nervous system, 2) Patients who have received another cancer therapy within 2 weeks before the planned day for the apheresis, 3) Patients who receive or are planned to receive any other investigational product within the 3 weeks before the planned day for the first NKR-2 administration, 4) Patients who are planned to receive concurrent growth factor, systemic steroid or other immunosuppressive therapy or cytotoxic agent, 5) Patients who have received other cell therapies, 6) Patients who underwent major surgery within 4 weeks before the planned day for the first NKR-2 administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the Phase I segment is to document and characterize the maximum tolerated dose (MTD) and the recommended Phase II dose (RP2D) of the NKR-2 treatment. The primary objective of the Phase II segment is to document and characterize the clinical activity of the NKR-2 treatment in each tumor type.;Secondary Objective: The secondary objective of the Phase I segment is to document and characterize additional indicators of safety and indicators of clinical activity. The secondary objective of the Phase II segment is to document and characterize additional indicators of clinical activity in each tumor type and indicators of safety, including the occurrence of DLTs.;Primary end point(s): Primary endpoint of the Phase I segment : Occurrence of DLTs in all patients during the study treatment until 14 days after the last study treatment administration. Primary endpoint of the Phase II segment : Objective Response Rate (ORR).;Timepoint(s) of evaluation of this end point: Phase I segment : The DLT safety period evaluation for each patient last from first NKR-2 infusion untill 2 weeks (D43) post last (3rd) NKR-2 infusion. Phase II segment: The ORR will be assessed at visit D57 (1 month post 3rd NKR-2 infusion-) and then at M3, M6, M9, M12, M18 and M24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint of the Phase I segment : 1) Occurrence of adverse events (AEs) and serious adverse events (SAEs) during the study treatment until 30 days after the last study treatment administration, 2) Occurrence of objective clinical response (complete response [CR], partial response [PR] and stable disease [SD]), 3) For solid tumors, occurrence of mixed response (MR), 4) Progression-free survival at 2 years (PFS), 5) Overall survival (OS), 6) Duration of response for patients with CR, PR or SD. Secondary endpoint of the Phase II segment : 1) For solid tumors, occurrence of MR, 2) PFS at 2 years, 3) OS, 4) Duration of response for patients with CR, PR or SD, 5) Occurrence of DLTs in all patients during the study treatment until 14 days after the last study treatment administration, 6) Occurrence of AEs and SAEs during the study treatment until 30 days after the last study treatment administration. ;Timepoint(s) of evaluation of this end point: Secondary timepoints (Phase I segment) : 1) Assessment until 30 days after the last study treatment administration 2-3) CR, PR, SD and MR will be assessed at visit D57 and then at M3, M6, M9, M12, M18 and M24. 4) Progression-free survival at 2 years 5-6) Kaplan-Meier curve will be estimated at Day 57 and then at M3, M6, M9, M12, M18 and M24. Secondary timepoints (Phase II segment) : 1) MR will be assessed at visit D57 and then at M3, M6, M9, M12, M18 and M24. 2) PFS at 2 years 3)Kaplan-Meier curve will be estimated at Day 57 and then at M3, M6, M9, M12, M18 and M24. | — |
Countries
Belgium, United States
Contacts
Public ContactClinical Trial Information
Celyad SA
Outcome results
None listed