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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

Study acronym: TINKS
StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Study sites: 21 to 22v23
  2. Study sites: 20 to 21v22
  3. Study sites: 19 to 20v21
  4. Study sites: 16 to 19v20
  5. Site details revised at 5 of 16 sitesv19
Show 17 earlier versionsHide 17 earlier versions
  1. Eligibility criteria expanded, about 205 words
    • Site contacts updated at 16 of 16 sites
    v18
  2. Study sites: 15 to 16v17
  3. Primary completion date: Dec 2026 to Dec 1, 2026
    • Study completion date: Dec 2027 to Dec 1, 2027
    v16
  4. Study sites: 13 to 15v15
  5. Study sites: 12 to 13v14
  6. Site details revised at 1 of 12 sitesv13
  7. Site details revised at 1 of 12 sitesv12
  8. Study sites: 11 to 12v11
  9. Study sites: 10 to 11v10
  10. Study sites: 8 to 10v9
  11. Site details revised at 1 of 8 sitesv8
  12. Study sites: 7 to 8v7
  13. Site details revised at 2 of 7 sitesv6
  14. Study sites: 2 to 7v5
  15. Study sites: 3 to 2
    • Collaborators expanded, about 4 words
    v4
  16. Study sites: 2 to 3v3
  17. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Dec 2022 to Nov 14, 2022
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05634369
Lead Sponsor Nationwide Children's Hospital
Collaborators: National Pediatric Cancer Foundation
Conditions
(from sponsor)		 Pediatric Sarcoma, Refractory, Pediatric Sarcoma, Relapsed
Related terms Recurrence
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov