TINKS: 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
This is a multi-center study for patients with childhood sarcomas that have relapsed or not responded to prior therapies. This study, sponsored by Nationwide Children’s Hospital is open to children and adults ages 12 to 40 years old in the United States with relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or non-rhabdomyosarcoma soft tissue sarcoma.
Patients eligible for this trial will receive two kinds of medications as part of the study. Chemotherapy and a type of immune cell called “natural killer” cells imprinted for a protein called TGFβ (TGFβi NK cells). Doctors and researchers are trying to determine if adding an infusion of these NK cells to sarcoma chemotherapy can improve outcomes without too much toxicity.
Patients will receive study drugs in 21 day cycles and may receive up to 8 cycles. The drugs include: Gemcitabine (GEM) by infusion into a vein on Days 1 and 8 Docetaxel (DOX) by infusion into a vein on Day 8. The TGFβi NK cells will be delivered by infusion into a vein on Day 12. Patients will also receive two drugs to help manage known symptoms related to treatment: dexamethasone on day 7-9 to prevent fluid retention and hypersensitivity reaction and Peg-filgrastim (PEG-GCSF) on day 9 to help white blood cells recover and allow more chemotherapy to be given.
This study will help doctors and scientists understand if adding TGFβi NK cells to GEM/DOX chemotherapy is safe and effective.
There are additional eligibility and exclusion criteria, including minimum organ function requirements and prior therapy considerations. Patients interested in this study should review these criteria with their doctor. To learn more about this study, patients and/or caregivers can talk to their doctor, contact the investigator at the site nearest you or your primary treatment center, or contact the study coordinator.
ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT05634369