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Intermediate-size IND for Treatment of KRAS G12V-mutant Tumors

NCT05389514 · Status: TEMPORARILY_NOT_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-11-20

No results posted yet for this study

Summary

This intermediate-size IND will treat participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation and appropriate HLA class II match (HLA-DRB1\*07:01).

Conditions

  • KRAS G12V Mutant Advanced Epithelial Cancers

Interventions

DRUG

Cyclophosphamide

Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.

DRUG

Gemcitabine

Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.

DRUG

Pembrolizumab

Patients will receive the anti-PD-1 immune checkpoint inhibitor pembrolizumab 200 mg IV over 30 minutes on Day -1 and will be dosed every 3 weeks.

BIOLOGICAL

Cell Infusion

Patient's T cells will be administered at a dose of between 1 x 10\^9 to 5.0 x 10\^10 TCR-transduced lymphocytes, which is a dose of genetically modified T cells that can be safely administered and is capable of mediating tumor regression in some patients with metastatic cancers. The cells are to be infused intravenously over approximately 30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.

Sponsors & Collaborators

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Matthew Taylor, MD · Providence Health & Services

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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Drugs

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 NCT05389514 on ClinicalTrials.gov