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Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia

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

Record History

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  1. 5 versions Re-verified since Apr 19, 2023, no change to tracked fieldsv14-v18
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Jun 2021 to Sep 13, 2021
    • Study completion date: Mar 2033 to Jul 2033
    • Site details revised
    v13
  3. Primary completion date: Mar 2021 to Jun 2021v12
  4. Primary completion date: Dec 2020 to Mar 2021
    • Study completion date: Dec 2032 to Mar 2033
    • Study description revised
    v11
  5. Primary completion date: Aug 2020 to Dec 2020v10 Show 4 more changesShow less
    • Study completion date: Jul 2032 to Dec 2032
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study arms: 3 to 4
    • Eligibility criteria expanded, about 1 word
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Site contact updatedv8
  3. Re-verified, no change to tracked fieldsv7
  4. Start date changed from estimate of Jul 2017 to Aug 4, 2017v6
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v5
  6. Eligibility criteria shortened, about 3 wordsv4
  7. Re-verified, no change to tracked fieldsv3
  8. Primary endpoints revised (2)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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.
Trial Details
NCT Number NCT03186118
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 CD 19+ Acute Leukemia
Related terms Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov