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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: Active Phase 1 study of Osteosarcoma, sponsored by Seattle Children's Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The type, frequency, severity, and duration of adverse events will be summarized
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 |
What the registry record for NCT05312411 still lists
NCT05312411 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 301-participant average among 46 other Osteosarcoma trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05312411's enrollment target sits among peer trials
21 35th of 46 higher than 11 of 46 other Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteosarcoma 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.
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