drugset / Trial / NCT03684889

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

NCT03684889 ↗

Phase 1 Active not recruiting 16 enrolled Seattle Children's Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2018-11-28
Primary completion
2021-02-08
Completion
2036-12

Drugs

EvaluationDrugModalityDoseRoute
Subject SCRI-huCAR19v1 Cell therapy — —
Subject SCRI-huCAR19v2 Cell therapy — —

Indications