drugset / Trial / NCT01493453

A Phase I Study of CD19 Specific T Cells in CD19 Positive Malignancy

NCT01493453 ↗

Phase 1 Terminated 17 enrolled The Christie NHS Foundation Trust
NaSingle-groupOpen-labelTreatment

Summary

In particular circumstances T cells can be an effective treatment for malignant disease, for example, donor lymphocyte infusions following allogeneic transplants or treatment of EBV related lymphomas post allograft. However, many common cancers are poorly recognised by the immune system in part because of a lack of suitable T cell targets and in part because of defects in antigen presentation by tumours (Garrido, et al 1997). Genetically modified T cells engineered to express chimeric immune receptors (CIRs) on their cell surface can bypass the need for MHC presentation and thus represent an attractive approach to immunotherapy (Gross, et al 1989).

Timeline

Start
2008-03
Primary completion
2014-12
Completion
2019-06

Outcome

Outcome not reported

Stopped: “Investigation into serious breach”

Drugs

EvaluationDrugModalityDoseRoute
Subject aCD19z cells Cell therapy 1e+09 cells Intravenous
Background Cyclophosphamide Other / unclassified 15 mg/kg —
Background Fludarabine Small molecule 25 mg/m2 —
Background IL-2 Protein / enzyme biologic — Intravenous