drugset / Trial / NCT02498912
Cyclophosphamide Followed by Intravenous and Intraperitoneal Infusion of Autologous T Cells Genetically Engineered to Secrete IL-12 and to Target the MUC16ecto Antigen in Patients With Recurrent MUC16ecto+ Solid Tumors
Phase 1
Active not recruiting
18 enrolled
Memorial Sloan Kettering Cancer Center
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · collabStanford University · collab
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 called "modified T cells". In the screening part of this study the tumor was found to have a protein called MUC16. This protein is present on about 70% of ovarian cancers. The investigators want to find a safe dose of modified T cells for patients with this type of cancer that has progressed after standard chemotherapy. We also want to find out what effects these modified T cells have on the patient and their cancer.
Timeline
- Start
- 2015-08
- Primary completion
- 2026-08
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 4H11-28z/fIL-12/EGFRt+ | Cell therapy | 300000 cells/kg | Intravenous |
| Subject | 4H11-28z/fIL-12/EGFRt+ | Cell therapy | 1e+06 cells/kg | Intravenous |
| Subject | 4H11-28z/fIL-12/EGFRt+ | Cell therapy | 3e+06 cells/kg | Intravenous |
| Subject | 4H11-28z/fIL-12/EGFRt+ | Cell therapy | 1e+07 cells/kg | Intravenous |
| Subject | 4H11-28z/fIL-12/EGFRt+ | Cell therapy | 3e+07 cells/kg | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 300 mg/m2 | — |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 25 mg/m2 | — |
| Subject | Fludarabine | Small molecule | 30 mg/m2 | — |