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NCT05634369 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Pediatric Sarcoma, Refractory and Pediatric Sarcoma, Relapsed, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 20
- Study locations
NCT05634369 is a Phase 1 study of Pediatric Sarcoma, Refractory and Pediatric Sarcoma, Relapsed that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 50 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT05634369, a Phase 1 study of Pediatric Sarcoma, Refractory and Pediatric Sarcoma, Relapsed, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 20
- Study locations
Study 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
Conditions Studied
Interventions
- BIOLOGICAL GEM/DOX + TGFBi expanded NK cells
Study Locations (20)
Florida
- University of Florida - Gainesville
- Nemours Jacksonville - Jacksonville
- University of Miami - Miami
- Johns Hopkins All Children's Hospital - St. Petersburg
North Carolina
- University of North Carolina - Chapel Hill
- Levine Cancer Institute - Charlotte
- Duke Children's Hospital/Duke Health - Durham
California
- Children's Hospital of Los Angeles - Los Angeles
- Stanford University - Palo Alto
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Montefiore Medical Center - The Bronx
Ohio
- Cleveland Clinic - Cleveland
- Nationwide Children's Hospital - Columbus
Alabama
- University of Alabama - South Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-11-14 |
| Est. Completion | 2027-12-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05634369
The ClinicalTrials.gov registry entry for NCT05634369 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Pediatric Sarcoma, Refractory appearing as the primary indexed condition, and to 1 intervention - of which GEM/DOX + TGFBi expanded NK cells is the first listed.
NCT05634369 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, North Carolina, California.
Frequently Asked Questions
What is clinical trial NCT05634369 about?
NCT05634369 is a clinical study titled "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". 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 ...
What is the current status of trial NCT05634369?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-11-14. Estimated completion is 2027-12-01.
What conditions does trial NCT05634369 study?
This clinical trial studies the following conditions: Pediatric Sarcoma, Refractory, Pediatric Sarcoma, Relapsed.
What interventions are being tested in trial NCT05634369?
The interventions under investigation include: GEM/DOX + TGFBi expanded NK cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05634369?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05634369 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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