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NCT02311621 · ClinicalTrials.gov registry record · Phase 1
Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01
A Phase 1 study of Neuroblastoma and Ganglioneuroblastoma, sponsored by Seattle Children's Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT02311621: Active Phase 1 study of Neuroblastoma and Ganglioneuroblastoma, sponsored by Seattle Children's Hospital.
NCT02311621 is a Phase 1 study of Neuroblastoma and Ganglioneuroblastoma that is active but no longer recruiting, run by Seattle Children's Hospital. The registered enrollment target is 65 participants, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311621, a Phase 1 study of Neuroblastoma and Ganglioneuroblastoma, is active but no longer recruiting, sponsored by Seattle Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients with recurrent or refractory neuroblastoma are resistance to conventional chemotherapy. For this reason, the investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T cell to recognize and kill the neuroblastoma cell through the recognition of CD171, a protein expressed of the surface of the neuroblastoma cell in patients with neuroblastoma. This is a phase 1 study designed to determine the maximum tolerated dose of the CAR+ T cells.
Primary Outcome
Patients will be evaluated through day 28 for occurrence of dose limiting toxicity
Conditions Studied
Interventions
- BIOLOGICAL Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells)
- BIOLOGICAL Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells)
- BIOLOGICAL Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells)
Study Locations (1)
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2014-11-25 |
| Est. Completion | 2038-11 |
| Phase | Phase 1 |
What the registry record for NCT02311621 still lists
NCT02311621 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 238-participant average among 94 other Neuroblastoma trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) is the first listed.
NCT02311621 reports a single indexed study location in Washington.
Frequently Asked Questions
What is clinical trial NCT02311621 about?
NCT02311621 is a clinical study titled "Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01". Patients with recurrent or refractory neuroblastoma are resistance to conventional chemotherapy. For this reason, the investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR). The CAR enables the T ...
What is the current status of trial NCT02311621?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2014-11-25. Estimated completion is 2038-11.
What conditions does trial NCT02311621 study?
This clinical trial studies the following conditions: Neuroblastoma, Ganglioneuroblastoma.
What interventions are being tested in trial NCT02311621?
The interventions under investigation include: Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) (BIOLOGICAL), Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells) (BIOLOGICAL), Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02311621?
This trial is sponsored by Seattle Children's Hospital, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02311621 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 Neuroblastoma
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 NCT02311621's enrollment target sits among peer trials
65 43rd of 94 higher than 52 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma 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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