Phase 1Terminated
A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML)
A Phase 1, Multicenter, Open-Label, Dose Escalating Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (RHIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML).
- Sponsor
- Celularity Incorporated (Industry)
- Enrollment
- 10 enrolled
- Conditions
- Leukemia, Myeloid, Acute
- Interventions
- PNK-007; Cyclophosphamide; Fludarabine; Human recombinant Interleukin-2 (rhIL-2)
- Ages
- adults, older adults
- Registry
- NCT02781467
Full record on ClinicalTrials.gov
From the registry
This study will find the highest acceptable treatment dose of cord blood, culture expanded natural killer (NK) cells, a kind of immune cell, in patients with relapsed and/or refractory acute myeloid leukemia. The NK cells will be given with chemotherapy and Recombinant human interleukin 2 (rhIL-2) to help the NK cells expand in the body. The safety of this treatment will be studied and researchers want to learn if NK cells will help in treating the AML.
Primary outcomes
- Dose-Limiting Toxicity (DLT)
- Maximum Tolerated Dose (MTD)
- Adverse Events (AEs)
History
Last registry update
Primary completion
Started
Registered