An expanded access record providing Cyclophosphamide and Gemcitabine in KRAS G12V Mutant Advanced Epithelial Cancers, sponsored by Providence Health & Services. No longer available. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Providence Health & Services · Expanded access
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).
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).
Providence Health & Services is the lead sponsor of 84 studies on the registry; 6 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with incurable, advanced or cancer, harboring KRAS G12V mutation, and appropriate HLA class II match (HLA-DRB1*07:01)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive a single dose of cyclophosphamide 60 mg/kg IV in 250 ml D5W over 2 hours on Day -3.
Also known as: Cytoxan, Cytoxan Lyophilized, Cy
Patients will receive a single dose of gemcitabine 600 mg/mg2 IVPB over 30 minutes on Day -2.
Also known as: Gemzar
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.
Also known as: KEYTRUDA, MK-3475
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.
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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