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NCT05312411 · ClinicalTrials.gov registry record · Phase 1
A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma
A Phase 1 study of Osteosarcoma, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT05312411 is a Phase 1 study of Osteosarcoma that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 21 participants, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05312411, a Phase 1 study of Osteosarcoma, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to see if a new treatment could help patients who have osteosarcoma that does not go away with treatment (is refractory) or comes back after treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and genetically modified chimeric antigen receptor T lymphocyte (CAR T) cells, which work together in a way that is different from chemotherapy. In this study, researchers will take some of your blood and remove the T cells in a process called "apheresis". Then the T cells are taken to a lab and changed to CAR T cells that recognize the flags from UB-TT170. Once researchers think they have grown enough CAR T cells, called antiFL(FITC-E2) CAR T cells, to fight your cancer, you may get some chemotherapy to make room in your body for the new cells and then have those cells put back in your body. A few days after the you get your CAR T cell infusion you will start to get infusions of UB-TT170, with the dose slowly increasing for the first few infusions until you have reached a maximum dose that you will get on a regular schedule. The UB-TT170 will attach to your tumor cells and flag them so that they attract the CAR T cells. When the CAR T cells see the labeled tumor cells they can kill the tumor cells. The active part of the study lasts about 8 months, and if you get the CAR T cell infusion you will be in long-term follow-up for 15 years.
Conditions Studied
Interventions
- BIOLOGICAL SCRI-E2CAR_EGFRtv1
- DRUG UB_TT170
Study Locations (1)
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2022-05-20 |
| Est. Completion | 2040-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05312411
The ClinicalTrials.gov registry entry for NCT05312411 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower). The listed sponsor is Seattle Children's Hospital, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Osteosarcoma appearing as the primary indexed condition, and to 2 interventions - of which SCRI-E2CAR_EGFRtv1 is the first listed.
NCT05312411 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT05312411 about?
NCT05312411 is a clinical study titled "A Phase I Feasibility And Safety Study of Fluorescein-Specific (FITC-E2) CAR T Cells In Combination With Parenterally Administered Folate-Fluorescein (UB-TT170) For Osteogenic Sarcoma". The purpose of this study is to see if a new treatment could help patients who have osteosarcoma that does not go away with treatment (is refractory) or comes back after treatment (is recurrent).This study is testing a combination of study therapies, UB-TT170 and genetically modified chimeric antige...
What is the current status of trial NCT05312411?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2022-05-20. Estimated completion is 2040-05.
What conditions does trial NCT05312411 study?
This clinical trial studies the following conditions: Osteosarcoma.
What interventions are being tested in trial NCT05312411?
The interventions under investigation include: SCRI-E2CAR_EGFRtv1 (BIOLOGICAL), UB_TT170 (DRUG).
Who is sponsoring clinical trial NCT05312411?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05312411 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.