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CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Seattle Children's Hospital to Seattle Children's Hospital
    • Eligibility criteria expanded, about 29 words
    • Site details revised at 2 of 2 sites
  2. 4 versions Re-verified since Apr 19, 2023, no change to tracked fieldsv15-v18
  3. Phase: Phase 1/2 to Phase 1v14
  4. Primary completion date changed from estimate of Dec 2021 to Feb 8, 2021v13
  5. Trial status: Suspended to Active, Not Recruiting
    • Enrollment target: estimated 112 to confirmed 16
    v12
Show 10 earlier versionsHide 10 earlier versions
  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Suspended Sponsor's reason: Study halted pending review of safety event
    • Site details revised at 2 of 2 sites
    v10
  3. Primary endpoints revised (2)
    • Site contacts updated at 1 of 2 sites
    v9
  4. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 2 of 2 sites
    v8
  5. Study sites: 1 to 2
    • Interventions: SCRI-huCAR19v1 (Biological) to SCRI-huCAR19v1 (Biological), SCRI-huCAR19v2 (Biological)
    • Eligibility criteria expanded, about 21 words
    • Study arms: 1 to 2
    v7
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: 107 to 112
    • Site details revised
    v6
  7. Eligibility criteria expanded, about 27 wordsv5
  8. Eligibility criteria expanded, about 56 wordsv4
  9. Start date changed from estimate of Nov 2018 to Nov 28, 2018v3
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Eligibility criteria expanded, about 22 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.
Trial Details
NCT Number NCT03684889
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 Leukemia, Lymphoma
Related terms Leukemia, Lymphoma
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov