drugset / Trial / NCT05989204
TmCD19-IL18 in CD19+ Cancers
Phase 1
Active not recruiting
26 enrolled
University of Pennsylvania
Kite, A Gilead Company · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase I, open-label dose finding study to assess the safety and feasibility, pharmacokinetics, and preliminary efficacy of TmCD19-IL18 CAR T cells in patients with CD19+ cancers. This study will take place in two parts: a Dose-Finding Phase to determine the maximum tolerate dose (MTD), followed by a Dose Expansion Phase. In the Dose-Finding Phase, dose levels will be evaluated using a 3+3 dose escalation design to determine the MTD. Cumulative safety experience and manufacturing feasibility data from the Dose-Finding Phase will then be used to identify the dose level that can be progressed into the Dose Expansion Phase.
Timeline
- Start
- 2023-11-13
- Primary completion
- 2026-10-01
- Completion
- 2041-10-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TmCD19-IL18 | Cell therapy | 2e+06 cells | Intravenous |
| Subject | TmCD19-IL18 | Cell therapy | 5e+06 cells | Intravenous |
| Subject | TmCD19-IL18 | Cell therapy | 7e+06 cells | Intravenous |
| Subject | TmCD19-IL18 | Cell therapy | 2e+07 cells | Intravenous |
| Subject | TmCD19-IL18 | Cell therapy | 6e+07 cells | Intravenous |