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A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 3 changed
See other at-risk trials from Seattle Children's Hospital

Record History

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  1. Primary endpoint(s) modified
    • Results posted: Sep 11, 2026
    • Final enrollment: 35 participants (planned 42)
    v13
  2. Primary endpoints revised (3)
    • Enrollment target: estimated 42 to confirmed 35
    v12
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 5 to 4
    • Primary completion date changed from estimate of Aug 2025 to Aug 8, 2025
    v11
  4. Primary completion date: Jun 2025 to Aug 2025v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary endpoints revised (3)
    • Site contacts updated at 1 of 5 sites
    v8
  2. Primary completion date: Jun 2024 to Jun 2025
    • Study completion date: Feb 2039 to Feb 2040
    • Site details revised at 1 of 5 sites
    v7
  3. Primary completion date: Apr 2023 to Jun 2024
    • Study completion date: Feb 2038 to Feb 2039
    v6
  4. Site details revised at 1 of 5 sitesv5
  5. Study sites: 3 to 5v4
  6. Study sites: 1 to 3v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2020 to Sep 25, 2020
    • Site details revised
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level 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 NCT04571138
Lead Sponsor Seattle Children's Hospital
Conditions
(from sponsor)		 Leukemia, Lymphoma
Related terms Leukemia, Lymphoma
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov