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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: Recruiting Phase 1 study of Pediatric Sarcoma, Refractory and Pediatric Sarcoma, Relapsed, sponsored by Nationwide Children's Hospital.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Evaluation of DLT in patients enrolled during Part 1 enrollment * ≥2 of 6 patients with DLT will be cause for termination of the study
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 |
What NCT05634369 shows while recruiting
NCT05634369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05634369's enrollment target sits among peer trials
50 974th of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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