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UNKNOWN
NCT07614048

Intermediate-size IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express TCR Targeting Mutant KRAS

Sponsor: Providence Health & Services

View on ClinicalTrials.gov

Summary

The goal of this intermediate-size expanded access treatment program is to treat a subset of patients with advanced solid cancers, specifically pancreatic ductal adenocarcinoma (PDAC) and colorectal cancer (CRC), that express KRAS-G12D and the appropriate HLA with adoptive t-cell therapy. Participants will provide leukapheresis product which will be processed and generated in our facility. The participant's peripheral blood T cells will be stimulated and then transduced with GMP-grade retroviral vectors encoding KRAS-G12D-neoantigen reactive TCR. On Days -6 to -4, the participant will receive outpatient chemotherapy as a preparative regimen. On Day 0, participant will receive cell product infusion as an inpatient procedure. Following infusion, participant will receive supportive care through discharge.

Official title: Intermediate-size Patient Population IND for Treatment of Patients With Advanced Cancer Using T Cells Engineered to Express T-cell Receptors (TCR) Targeting Mutant KRAS

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

EXPANDED_ACCESS

Enrollment

Not specified

Start Date

Not specified

Completion Date

Not specified

Last Updated

2026-05-29

Healthy Volunteers

Not specified

Interventions

DRUG

Cyclophosphamide

Patients will receive 300 mg/m2/day IV cyclophosphamide as part of a conditioning regimen on Days -6 to -4.

DRUG

Fludarabine

Patients will receive 30 mg/m2/day fludarabine as part of a conditioning regimen on Days -6 to -4.

BIOLOGICAL

Cell infusion

Cells will be administered at a dose of between 1x109 to 1x1010 TCR-T cells. If manufactured product does not meet target range, product may still be administered with Investigator discretion.