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Clinical trialNCT05634369RecruitingPhase 1/PHASE2Interventional

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

SponsorNationwide Children's HospitalEnrollment50Pediatric Sarcoma, RefractoryPediatric Sarcoma, Relapsed
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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, TGFβ imprinted (TGFβi), 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 + TGFβi 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 * TGFβi NK cells: via IV on Day 12

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

22 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of Alabama

    South Birmingham, Alabama, United States

    Elizabeth Alva, MD
    Recruiting
  • Phoenix Children'S Hospital

    Phoenix, Arizona, United States

    Mona Nourani, MD
    Recruiting
  • Arkansas Children'S Hospital

    Little Rock, Arkansas, United States

    David Douglas, MD
    Recruiting
  • Children'S Hospital of Los Angeles

    Los Angeles, California, United States

    Fariba Navid, MD
    Recruiting
  • Stanford University

    Palo Alto, California, United States

    Raya Hamad Saab, MD
    Recruiting
  • University of Florida

    Gainesville, Florida, United States

    John Ligon, MD
    Recruiting
  • Nemours Jacksonville

    Jacksonville, Florida, United States

    Anderson Collier, III, MD
    Recruiting
  • University of Miami

    Miami, Florida, United States

    Aditi Dhir, MD
    Recruiting
  • Johns Hopkins All Children'S Hospital

    St. Petersburg, Florida, United States

    Natalie Booth, DO
    Recruiting
  • Washington University/st Louis Childrens

    St Louis, Missouri, United States

    Amy Armstrong, MD
    Recruiting
  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, United States

    Ajay Gupta, MD
    Recruiting
  • Montefiore Medical Center

    The Bronx, New York, United States

    Alice Lee, MD
    Recruiting
  • University of North Carolina

    Chapel Hill, North Carolina, United States

    Patrick Thompson, MD
    Recruiting
  • Levine Cancer Institute

    Charlotte, North Carolina, United States

    Erin M Trovillion, MD
    Recruiting
  • Duke Children'S Hospital/duke Health

    Durham, North Carolina, United States

    Jessica Sun, MD
    Recruiting
  • Cleveland Clinic

    Cleveland, Ohio, United States

    Matteo Trucco, MD
    Recruiting
  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

    Bhuvana Setty, MD
    Recruiting
  • Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

    Jacquelyn W Crane, MD
    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

    Scott Borinstein, MD
    Recruiting
  • Ut Southwestern

    Dallas, Texas, United States

    Avanthi Shah, MD
    Recruiting
  • University of Texas Md Anderson Cancer Center

    Houston, Texas, United States

    Irtiza Sheikh, MDJonathan Gill, MD
    Recruiting
  • Primary Children'S Hospital

    Salt Lake City, Utah, United States

    Matthew Dietz, DO
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GEM/DOX + TGFBi expanded NK cells
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
14 Nov 2022
Primary completion
1 Dec 2026
Completion
1 Dec 2027
Last update posted
28 Jan 2026
Registered enrollment
50
Registry id
NCT05634369

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.