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Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 6 versions Re-verified since May 2, 2022, no change to tracked fieldsv13-v18
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v12
  3. Enrollment target: 40 to 65
    • Primary completion date: Nov 2022 to Nov 2023
    • Study completion date: Nov 2037 to Nov 2038
    • Eligibility criteria expanded, about 5 words
    v11
  4. 3 versions Re-verified since Jun 8, 2019, no change to tracked fieldsv8-v10
  5. Start date: Nov 2014 to Nov 25, 2014
    • Site contact updated
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Interventions: Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) (Biological), Patient Derived CD171 specific CAR T… to Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) (Biological), Patient Derived CD171 specific CAR T…
    • Eligibility criteria shortened, about 497 words
    • Study arms: 2 to 3
    v6
  2. Primary completion date: Nov 2017 to Nov 2022
    • Study completion date: Nov 2037
    v5
  3. Enrollment target: 80 to 40
    • Eligibility criteria expanded, about 25 words
    • Collaborators expanded, about 10 words
    v4
  4. Eligibility criteria expanded, about 317 wordsv3
  5. Interventions: Patient Derived CD171 specific CAR T cells expressing EGFRt (Biological), Patient Derived CD171 specific CAR T cells expressing EGFRt… to Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells) (Biological), Patient Derived CD171 specific CAR T…
    • Eligibility criteria expanded, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02311621
Lead Sponsor Seattle Children's Hospital
Collaborators: The Evan Foundation, Ben Towne Center for Childhood Cancer Research
Conditions
(from sponsor)		 Neuroblastoma, Ganglioneuroblastoma
Related terms Ganglioneuroblastoma, Neuroblastoma
Enrollment 65 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov