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

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Providence Health & Services

Status

Conditions

KRAS G12V Mutant Advanced Epithelial Cancers

Treatments

Drug: Cyclophosphamide
Biological: Cell Infusion
Drug: Pembrolizumab
Drug: Gemcitabine

Study type

Expanded Access

Funder types

Other

Identifiers

NCT05389514
2020000471

Details and patient eligibility

About

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).

Full description

This study will treat two identified patients with metastatic pancreatic adenocarcinoma and metastatic pancreatic cancer who have both been treated with standard of care therapies and found to have disease progression. Both of these patients have KRAS G12V mutations in their cancers and express the HLA-DRB1*07:01 HLA class II molecule. As such, they are candidates for adoptive cell therapy with autologous gene-engineered T cells expressing HLA-DRB1*07:01-restricted KRAS G12V reactive T-cell receptors (TCR).

Adoptive T-cell therapy is a type of immunotherapy which involves isolation of T cells from a patient, followed by an amplification of those T cells in the lab to large numbers, and reinfusion of the T cells back to the patient.

In addition to the two identified patients, the protocol will remain open for additional participants with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (DRB1*07:01).

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Patients with incurable, advanced or metastatic cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)

Trial contacts and locations

0

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Central trial contact

Kim Sutcliffe, RN

Data sourced from clinicaltrials.gov

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