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

Recruiting Phase 1 Phase 2 Interventional Study
Pediatric Sarcoma, Refractory Pediatric Sarcoma, Relapsed
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
2 – 40
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Nationwide Children's Hospital · Other
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About This Trial
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 additi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients must be between the ages ≥ 2 years and ≤ 40 years of age and have had a relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. 2. Patients must have measurable disease using RECIST 1.1 criteria 3. Patients mu…
Contacts

Jessica Crimella, BSN, RN, CCRP

813-745-6250

jessica.crimella@moffitt.org

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