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  • Long-Term Follow-Up Protocol for Subjects Treated with Gene-Modified T Cells

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • 2019-106
    NCT ID
    • NCT03435796
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase II
    Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
    • Phase II
    Principal Investigator
    • Abhinav
      Deol, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Per Health Authority guidelines for gene therapy medicinal products that utilize integrating vectors (eg, retroviral vectors), long-term safety and efficacy follow up of treated subjects is required.
    The primary objectives of this study are as follows:
    • To assess the risk of delayed adverse events (AEs) following exposure to GM T cells.
    • To monitor for long-term persistence of GM T cells, including analysis of vector integration sites, as appropriate.
    • To monitor for generation of replication competent retroviruses (RCR).
    • To assess long-term efficacy following treatment with GM T cells.
    • Describe growth, developmental outcome, and sexual maturity status for subjects who were aged < 18 years at time of GM T cell therapy.
    • To assess long term health-related quality of life following treatment with GM T cells
  • Locations

    Locations

    Karmanos Cancer Institute - Detroit Headquarters

    4100 John R
    Detroit, MI 48201
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