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 (NCT05634369)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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 must have had at least one and no more than four total lines of cytotoxic systemic treatment for relapse sarcoma. Local control with surgical resection or radiation therapy of the primary tumor and any metastatic sites as clinically indicated as standard of care per the treating physician must be considered prior to enrollment.
4. Prior Therapy: Therapy may not have been received more recently than the timeframes defined below:
5. Myelosuppressive chemotherapy: Patients must not have received myelosuppressive therapy within 14 days of protocol therapy
6. Radiation: At least 2 weeks must have elapsed from the start of protocol therapy since local palliative XRT (small port); 4 weeks must have elapsed for all other radiation therapy
7. Hematopoietic Cell Transplant (HCT): Patients must have at least 6 weeks elapsed after autologous and allogeneic hematopoietic cell transplant
8. Biologic (anti-neoplastic agent): At least 7 days or 5 half-lives of the drug, whichever is longer, must have elapsed from the start of protocol therapy since the completion of therapy with a biologic agent.
9. Monoclonal antibodies: At least 3 weeks must have elapsed from the start of protocol therapy since prior therapy that included a monoclonal antibody.
10. Prior use of Gemcitabine and/or Docetaxel: Patients who have received these agents for prior treatment may be included if previous treatments were given ≥ 6 months prior to enrollment on this study, and there were no allergic reactions, pulmonary edema or fibrosis, Grade 3 or higher neuropathy or other non-hematologic Grade 4 adverse events related to gemcitabine and/or docetaxel therapies. 4\) Performance status: Karnofsky ≥ 60 for patients ≥16 years of age. Lansky score of ≥ 60 for patients \< 16 years of age (see Appendix A) 5) Organ Function Requirements: Patients must have normal organ and marrow function within 7 days of starting protocol therapy as defined below:
11. Absolute Neutrophil Count ≥1000/mcL
12. Platelet count ≥100,000/mcL transfusion independent defined as no platelet transfusions within the last 72 hours

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (22 Sites)

• University of Alabama — South Birmingham, Alabama
• Phoenix Children's Hospital — Phoenix, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• Children's Hospital of Los Angeles — Los Angeles, California
• Stanford University — Palo Alto, California
• University of Florida — Gainesville, Florida
• Nemours Jacksonville — Jacksonville, Florida
• University of Miami — Miami, Florida
• Johns Hopkins All Children's Hospital — St. Petersburg, Florida
• Washington University/St Louis Childrens — St Louis, Missouri
• Roswell Park Comprehensive Cancer Center — Buffalo, New York
• Montefiore Medical Center — The Bronx, New York
• University of North Carolina — Chapel Hill, North Carolina
• Levine Cancer Institute — Charlotte, North Carolina
• Duke Children's Hospital/Duke Health — Durham, North Carolina
• Cleveland Clinic — Cleveland, Ohio
• Nationwide Children's Hospital — Columbus, Ohio
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
• Vanderbilt University Medical Center — Nashville, Tennessee
• UT Southwestern — Dallas, Texas
• University of Texas MD Anderson Cancer Center — Houston, Texas
• Primary Children's Hospital — Salt Lake City, Utah

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.