Clinical Trial

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

Active, Not Recruiting Phase 1
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Summary
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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2018-09-24; most recent amendment 2025-08-07.
Status change: Suspended → Active, Not Recruiting 2021-02-08
Status change: Recruiting → Suspended 2021-01-22
Status change: Active, Not Recruiting → Recruiting 2020-10-28
Status change: Recruiting → Active, Not Recruiting 2020-02-24
Status change: Not Yet Recruiting → Recruiting 2018-11-10
Trial Details
NCT Number NCT03684889
Lead Sponsor Seattle Children's Hospital
Conditions Leukemia, Lymphoma
Enrollment 16 participants
Start Date 2018-11-28
Primary Completion 2021-02-08 (estimated)
Study Completion 2036-12 (estimated)
Updated on ClinicalTrials.gov 2025-08-12