drugset / Trial / NCT01493453
A Phase I Study of CD19 Specific T Cells in CD19 Positive Malignancy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |