CYAD-N2T-005 (DEPLETHINK) (R/R)
An Open-label, Phase I Study to Assess the Safety of NKR-2 Treatment Administration After a Non-myeloablative Preconditioning Chemotherapy in Relapse/Refractory Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Patients (DEPLETHINK)
Study Treatments
- Administration of NKR-2 cells
Inclusion criteria
- Age ≥ 18 years and ≤ 70 years
- A confirmed MDS with:
- R-IPSS criteria for Intermediate, High-risk or Very High-risk disease or refractory anemia with excess blasts by WHO or MDS with TP53 mutation
- Failure of prior treatment with at least 4 cycles of azacitidine or decitabine defined as no response to treatment, loss of response at any time point, or progressive disease/intolerance to therapy
- The absolute peripheral blast count should be < 15,000 per micro liter
- ECOG score 0-2
Exclusion criteria
- The patient has a confirmed or suspected tumor involvement in the central nervous system (CNS)
- Patients who have received any cancer therapy (investigational agent or not), including but not limited to chemotherapy, small molecules, monoclonal antibodies (e.g., immune checkpoint blockade therapies), or radiotherapy within 2 weeks before the planned day for the apheresis
- Patients who have received prior allogeneic stem cell transplantation or chimeric antigen receptor therapy
Participating sites
- Institut Jules Bordet