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

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 relapse

Trial Details

NCT ID
NCT05634369
Phase
PHASE1 / PHASE2
Sponsor
Nationwide Children's Hospital
Status
RECRUITING
Cancer Type
Osteosarcoma Sarcoma
Interventions
  • GEM/DOX + TGFBi expanded NK cells
Locations (sample)
  • South Birmingham, Alabama, United States
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Los Angeles, California, United States|34.05223,-118.24368
  • Palo Alto, California, United States|37.44188,-122.14302

Key Eligibility Criteria

  • Patients must be between the ages ≥ 2 years and ≤ 40 years of age and have had a relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarco…
  • Patients must have measurable disease using RECIST 1.1 criteria
  • Patients must have had at least one and no more than four total lines of cytotoxic systemic treatment for relapse sarcoma. Local control with surgi…
  • Prior Therapy: Therapy may not have been received more recently than the timeframes defined below:

For full eligibility, visit ClinicalTrials.gov.

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