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
Public ClinicalTrials.gov record NCT05634369. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT05634369
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 50 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Years to 40 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 13, 2022
- Primary completion
- Nov 30, 2026
- Completion
- Nov 30, 2027
- Last update posted
- Jan 27, 2026
2022 – 2027
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | South Birmingham | Alabama | 35233 | Recruiting |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | Recruiting |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | Recruiting |
| Children's Hospital of Los Angeles | Los Angeles | California | 90027 | Recruiting |
| Stanford University | Palo Alto | California | 94304 | Recruiting |
| University of Florida | Gainesville | Florida | 32610 | Recruiting |
| Nemours Jacksonville | Jacksonville | Florida | 32207 | Recruiting |
| University of Miami | Miami | Florida | 33136 | Recruiting |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | Recruiting |
| Washington University/St Louis Childrens | St Louis | Missouri | 63110 | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | Recruiting |
| Montefiore Medical Center | The Bronx | New York | 10467 | Recruiting |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | 28203 | Recruiting |
| Duke Children's Hospital/Duke Health | Durham | North Carolina | 27710 | Recruiting |
| Cleveland Clinic | Cleveland | Ohio | 44195 | Recruiting |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| UT Southwestern | Dallas | Texas | 75390 | Recruiting |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05634369, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 27, 2026 · Synced Jul 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05634369 live on ClinicalTrials.gov.