Study #2022-0995
A multi-institution study of TGFb; 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 sarcomas: The TiNKS Trial
MD Anderson Study Status
Enrolling
Treatment Agent
GEM/DOX + TGFBi expanded NK cells
Description
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies. The goals of this study are: * To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGF¦Â imprinted (TGF¦Âi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma. * To identify toxicities related to treatment with GEM/DOX + TGF¦Âi expanded NK cells Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles. * Gemcitabine (GEM): via IV on Days 1 and 8 * Docetaxel (DOX): via IV on Day 8 * Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction * Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given * TGF¦Âi NK cells: via IV on Day 12
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
Disease:
Pediatric Sarcoma, Refractory, Pediatric Sarcoma, Relapsed
Study phase:
Physician name:
Irtiza Sheikh
Department:
Pediatrics
For general questions about clinical trials:
1-877-632-6789
Help #EndCancer
Give Now
Donate Blood
Our patients depend on blood and platelet donations.
Shop MD Anderson
Show your support for our mission through branded merchandise.?