drugset / Trial / NCT05989204

TmCD19-IL18 in CD19+ Cancers

NCT05989204 ↗

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

EvaluationDrugModalityDoseRoute
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

Indications