drugset / Trial / NCT04670068
Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian
Phase 1
Active not recruiting
4 enrolled
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI) · collabNational Institutes of Health (NIH) · collab
NaSingle-groupOpen-labelTreatment
Summary
This is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.
Timeline
- Start
- 2021-01-27
- Primary completion
- 2024-12-19
- Completion
- 2030-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAR.B7-H3 | Cell therapy | 3.75e+06 cells | Other |
| Subject | CAR.B7-H3 | Cell therapy | 7.5e+07 cells | Other |
| Subject | CAR.B7-H3 | Cell therapy | 2e+08 cells | Other |
| Background | Cyclophosphamide | Other / unclassified | 300 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |