Cytokine Induced Memory-like NK Cell Adoptive Therapy After Haploidentical Donor Hematopoietic Cell Transplantation
Status:
Recruiting
Trial end date:
2024-01-30
Target enrollment:
Participant gender:
Summary
This is a standard phase 2 study powered to demonstrate improvement in the 100 day leukemia
free survival to 30% from <10% expected with the use of reduced intensity haplo-HCT in this
extremely high-risk patient cohort (based on the institutional experience using
non-myeloablative / reduced intensity conditioning in a similar patient cohort).
A formal safety evaluation will be done after every 6th patient enrolled and the trial will
be stopped if noted to have unusually higher engraftment failure (acute GVHD rates (>60% any
grades or >30% grade III/IV or ≥ 50% severe cGVHD) or engraftment failure rates (≥15%).
Phase:
Phase 2
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
ImmunityBio, Inc. National Cancer Institute (NCI) National Institutes of Health (NIH) The V Foundation for Cancer Research