drugset / Trial / NCT07594067

TCR1188-ABC Cells in KRAS-mutated Cancers

NCT07594067

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase I, open-label dose finding study to assess the safety, manufacturing feasibility, and preliminary efficacy of TCR1188-ABC cells in patients with KRAS-mutated cancers. Initially, patients with KRAS G12V mutation positive metastatic pancreatic adenocarcinoma, cholangiocarcinoma, colorectal cancer, or non-small cell lung cancer (NSCLC) will be targeted for participation. Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

Timeline

Start
2026-07
Primary completion
2042-07
Completion
2042-07

Drugs

EvaluationDrugModalityDoseRoute
Subject TCR1188-ABC cells Cell therapy 1.11e+08 cells Other
Subject TCR1188-ABC cells Cell therapy 3.33e+08 cells Other
Subject TCR1188-ABC cells Cell therapy 1e+09 cells Other
Subject TCR1188-ABC cells Cell therapy 3e+09 cells Other
Background Cyclophosphamide Other / unclassified 600 mg/m2
Background Fludarabine Small molecule 30 mg/m2
Background Tocilizumab Monoclonal antibody 8 mg/kg