drugset / Trial / NCT02096614
Investigator Initiated Phase 1 Study of TBI-1201
Phase 1
Completed
18 enrolled
Mie University
Fiverings Co., Ltd. · collabShionogi · collabStatcom Co. Ltd. · collabTakara Bio Inc. · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
Following pre-treatment with cyclophosphamide and/or fludarabine, MAGE-A4-specific TCR gene transduced T lymphocytes are transferred to the patients with MAGE-A4-expressing solid tumors.
Timeline
- Start
- 2014-04
- Primary completion
- 2021-03
- Completion
- 2021-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TBI-1201 | Cell therapy | 5e+08 cells | — |
| Subject | TBI-1201 | Cell therapy | 5e+09 cells | — |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 20 mg/m2 | Intravenous |