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

NCT07614048 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Binbin Zheng, MD · Providence Health & Services

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07614048 on ClinicalTrials.gov