Study of NK Cell Infusions with Gemcitabine and Docetaxel in Children and Young Adults with Relapsed or Resistant Pediatric Bone and Soft Tissue Sarcomas

What this Trial Is About

Researchers are evaluating whether adding infusions of a special type of immune cells called natural killer NK cells to the chemotherapy regimen gemcitabine and docetaxel GEMDOX can improve outcomes for children and young adults with sarcomas that have come back or did not respond to previous treatments. This study aims to determine the safety and effectiveness of this combined treatment in relapsed or refractory pediatric sarcomas, including osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, and other soft tissue sarcomas. The study is a multi-center, phase 1 and 2 trial with ongoing safety and toxicity analysis conducted by Nationwide Childrens Hospital. Participants receive up to 8 cycles of treatment, each lasting 21 days. Each cycle includes intravenous gemcitabine on days 1 and 8, docetaxel on day 8, oral dexamethasone on days 7 to 9 to prevent side effects, pegfilgrastim on day 9 to help white blood cells recover, and intravenous TGF-beta imprinted TGFb2i, ex vivo expanded universal donor NK cells on day 12. Tumor response is checked after cycles 2, 4, 6, and 8. The study carefully monitors for toxicities related to the combined treatment and tracks how well the NK cells persist in the body and relate to clinical outcomes. During the trial, participants undergo regular assessments including tumor measurements using the RECIST 1.1 criteria every two cycles, evaluation of treatment-related side effects, and laboratory tests to monitor blood counts and organ function. Safety and disease progression are followed for 3 to 5 years. The study also evaluates six-month progression-free survival to understand how well the treatment controls the cancer. Overall, participants will be closely monitored throughout the study and during long-term follow-up to assess the treatments effects and safety.

A Multi-Institution Study of TGFβ Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue