RecruitingPhase 1Phase 2NCT05634369

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


Sponsor

Nationwide Children's Hospital

Enrollment

50 participants

Start Date

Nov 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 2 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of natural killer (NK) cell therapy — a type of immune cell infusion — alongside chemotherapy drugs (gemcitabine and docetaxel) in children and young adults with bone and soft tissue cancers (such as osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma) that have come back or stopped responding to treatment. **You may be eligible if...** - You are between 2 and 40 years old - You have a relapsed or treatment-resistant osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, or related soft tissue sarcoma - Your disease is measurable on imaging **You may NOT be eligible if...** - You have not had prior treatment for your sarcoma - Your disease is not measurable - You have significant organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALGEM/DOX + TGFBi expanded NK cells

8 cycles consisting of gemcitabine, docetaxel, supportive dexamethasone and pegfilagrastim, and universal donor, TGFBi ex vivo expanded NK cells * Each cycle will be repeated every 21 days based upon disease response and toxicity criteria * Tumor response assessed after Cycles 2, 4, 6, and 8 1. Gemcitabine 675mg/m2/dose IV on Days 1 and 8 2. Docetaxel 75mg/m2/dose IV on Day 8 3. Dexamethasone 3mg/m2/dose (max 8 mg/dose) PO BID on Days 7, 8, and 9 4. Pegfilgrastim (Peg-GCSF) 0.1mg/kg/dose (max 6 mg/dose) SQ on Day 9 5. NK cells 1 x 10e8 cells/kg/dose IV on Day 12 (+ 1-2 days)


Locations(22)

University of Alabama

South Birmingham, Alabama, United States

Phoenix Children's Hospital

Phoenix, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's Hospital of Los Angeles

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

University of Florida

Gainesville, Florida, United States

Nemours Jacksonville

Jacksonville, Florida, United States

University of Miami

Miami, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Washington University/St Louis Childrens

St Louis, Missouri, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke Children's Hospital/Duke Health

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern

Dallas, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Primary Children's Hospital

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05634369