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Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01
NCT02311621 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02311621
The ClinicalTrials.gov registry entry for NCT02311621 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seattle Children's Hospital, which has 127 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02311621 reports 1 study location spanning 1 distinct geographic area — top geographies include Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02311621?
This trial is sponsored by Seattle Children's Hospital, which has 127 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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