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NOT YET RECRUITING
NCT07594067
PHASE1

TCR1188-ABC Cells in KRAS-mutated Cancers

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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.

Official title: Phase I, Open-Label Study of Autologous Mutant KRAS and ILT4-Redirected T-cell Receptor Cells (TCR1188-ABC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-07

Completion Date

2042-07

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

BIOLOGICAL

TCR1188-ABC cells

TCR1188 modified, base-edited autologous CD4+ and CD8+ T cells expressing TCR1188 and a scFv fragment specific to ILT4 (LILRB2) as a Single infusion on Day 0

DRUG

Fludarabine + Cyclophosphamide combination

Fludarabine: 30 mg/m2/day x 4 days (Day -7 to -4) Cyclophosphamide: 600mg/m2/day x 3 days (Day -7 to -5)

DRUG

Tocilizumab

Single administration of 8mg/kg on Day 2 (+3d)

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States