Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors
Status:
Active, not recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
Summary
The investigators hypothesize that this Phase 2 cellular and adoptive immunotherapy study
using human leukocyte antigen (HLA)-haploidentical hematopoietic cell transplantation (HCT)
followed by an early, post-transplant infusion of donor natural killer (NK) cells on Day +7
will not only be well-tolerated in this heavily-treated population (safety), but will also
provide a mechanism to treat high-risk solid tumors, leading to improved disease control rate
(efficacy). Disease control rate is defined as the combination of complete (CR) and partial
(PR) response and stable disease (SD). The investigators further propose that this infusion
of donor NK cells will influence the development of particular NK and T cell subtypes which
will provide immediate/long-term tumor surveillance, infectious monitoring, and durable
engraftment.
Patients with high-risk solid tumors (Ewings Sarcoma, Neuroblastoma and Rhabdomyosarcoma) who
have either measurable or unmeasurable disease and have met eligibility will be enrolled on
this trial for a goal enrollment of 20 patients over 4 years.