OncoMatch/Clinical Trials/NCT03190941
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Is NCT03190941 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Anti-KRAS G12V mTCR PBL and Cyclophosphamide for pancreatic cancer.
Treatment: Cyclophosphamide · Fludarabine · Anti-KRAS G12V mTCR PBL · Aldesleukin — Background: A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells. Objective: To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors. Eligibility: Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors. Design: In another protocol, participants will: Be screened Have cells harvested and grown Have leukapheresis In this protocol, participants will have the procedures below. Participants will be admitted to the hospital. Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest. A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter. For up to 3 days, participants will get a drug to make the cells active. A day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin. Participants will recover in the hospital for 1-2 weeks. They will have lab and blood tests. Participants will take an antibiotic for at least 6 months. Participants will have visits every few months for 2 years, and then as determined by their doctor. Visits will be 1-2 days. They will include lab tests, imaging studies, and physical exam. Some visits may include leukapheresis or blood drawn. Participants will have blood collected over several years.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Gastric Cancer
Colorectal Cancer
Hepatocellular Carcinoma
Cholangiocarcinoma
Esophageal Carcinoma
Biomarker criteria
Required: KRAS G12V
malignancy expressing G12V mutated KRAS as assessed by one of the following methods: RT-PCR on tumor tissue, tumor DNA sequencing, or any other CLIA-certified laboratory test on resected tissue
Required: NRAS G12V
Patients shown to have tumors expressing G12V mutated NRAS ... will also be eligible
Required: HRAS G12V
Patients shown to have tumors expressing G12V mutated ... HRAS will also be eligible
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — advanced cancer
previously received standard systemic therapy for their advanced cancer and have been either non-responders or have recurred
Lab requirements
Blood counts
ANC > 1000/mm^3 without the support of filgrastim; WBC ≥ 2500/mm^3; Platelet count ≥ 80,000/mm^3; Hemoglobin > 8.0 g/dL. Subjects may be transfused to reach this cut-off.
Kidney function
eGFR > 60 mL/m (based on serum creatinine and lab nomogram) or a formal 6-24h CrCl > 60 mL/m.
Liver function
Serum ALT/AST ≤ 5.0 times ULN; total bilirubin ≤ 2.0 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL.
Hematology: ANC > 1000/mm^3 without the support of filgrastim; WBC ≥ 2500/mm^3; Platelet count ≥ 80,000/mm^3; Hemoglobin > 8.0 g/dL. Chemistry: Serum ALT/AST ≤ 5.0 times ULN; total bilirubin ≤ 2.0 mg/dL, except in patients with Gilbert's Syndrome, who must have a total bilirubin < 3.0 mg/dL. Renal: eGFR > 60 mL/m (based on serum creatinine and lab nomogram) or a formal 6-24h CrCl > 60 mL/m.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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