drugset / Trial / NCT03085173

A Trial of "Armored" CAR T Cells Targeting CD19 For Patients With Relapsed CD19+ Hematologic Malignancies

NCT03085173 ↗

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this phase I study is to test the safety of different dose levels of specially prepared cells collected from the patient called "modified T cells". The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard therapy. The investigators also want to find out what effects these modified T cells have on the patient and the cancer. For patients who were treated, had progression of disease and were removed from study, duplicate enrollment is permitted if it is determined the patients could receive a benefit. If the patients meet all eligibility criteria, they can be enrolled onto study a second time as a new accrual, and receive treatment in a higher dose level cohort.

Timeline

Start
2017-03-15
Primary completion
2027-03
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Subject EGFRt/19-28z/4-1BBL CAR T cells Cell therapy 100000 cells/kg —
Subject EGFRt/19-28z/4-1BBL CAR T cells Cell therapy 300000 cells/kg —
Subject EGFRt/19-28z/4-1BBL CAR T cells Cell therapy 1e+06 cells/kg —
Subject EGFRt/19-28z/4-1BBL CAR T cells Cell therapy 3e+06 cells/kg —