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Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation

StatusRecruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Minor 3 versions Re-verified since Feb 5, 2024, no change to tracked fieldsv14-v16
  2. Notable Primary completion date: Aug 2022 to Dec 2028
    • Study completion date: Oct 2022 to Dec 2028
    v13
  3. Minor Re-verified, no change to tracked fieldsv12
  4. Notable Primary completion date: Aug 2021 to Aug 2022
    • Study completion date: Oct 2021 to Oct 2022
    v11
  5. Notable Lead sponsor: Case Comprehensive Cancer Center to Mari Dallas
    • Primary completion date: Oct 2020 to Aug 2021
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary completion date: Mar 2020 to Oct 2020
    • Study completion date: Mar 2021 to Oct 2021
    v9
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2019 to Jan 4, 2019
    • Site details revised
    v8
  3. Notable Start date: Dec 2018 to Feb 2019v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Notable Start date: Sep 2018 to Dec 2018v5
  6. Notable Start date: Jun 2018 to Sep 2018
    • Primary completion date: Dec 2019 to Mar 2020
    • Study completion date: Dec 2020 to Mar 2021
    v4
  7. Minor Eligibility criteria shortened, about 168 wordsv3
  8. Notable Start date: Dec 2017 to Jun 2018v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to determine if it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into the patient, to try to give the immune system the ability to fight the infection. Adoptive T cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).
Trial Details
NCT Number NCT03378102
Lead Sponsor Mari Dallas
Conditions
(from sponsor)
Allogeneic Hematopoietic Stem Cell Transplantation
Related terms Opportunistic Infections
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov