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Safety/PK Study of Gene Modified Donor T Cell Infusion in Children With Recurrent Hem Malignancies After Allo Transplant

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 12, 2022 (before its estimated September 2022 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Primary completion date: Jul 2022 to Sep 2022 Completion date: Jul 2035 to Sep 2035 · Eligibility criteria expanded, about 40 words · Secondary endpoints revised (2) · 1 morev8 Show 4 more changesShow less
    • Completion date: Jul 2035 to Sep 2035
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints revised (2)
    • Primary endpoints revised (2)

    See this version in full on ClinicalTrials.gov ↗

  2. Notable Primary completion date: Mar 2020 to Jul 2022 Primary endpoints revised (2) · Trial status: Recruiting to Active, Not Recruiting · Completion date: Mar 2035 to Jul 2035 · 4 morev7 Show 7 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Mar 2035 to Jul 2035
    • Eligibility criteria expanded, about 123 words
    • Secondary endpoints: 1 to 2
    • Study description revised
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Completion date: Mar 2033 to Mar 2035v6
  4. Minor 4 versions Re-verified since Aug 24, 2018, no change to tracked fieldsv2-v5
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Phase I, open-label, non-randomized study of safety, pharmacokinetics and efficacy of donor BPX-501 T cell infusion in children with recurrent or minimal residual disease (MRD) hematologic malignancies post-allogeneic transplant. The study will consist of the Main Study and an optional Pharmacokinetics (PK) Sub-Study.
Trial Details
NCT Number NCT03459170
Lead Sponsor Bellicum Pharmaceuticals
Conditions Hematologic Malignancy
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov