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 (Jun 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
Treatments studied
Chemotherapy
Other
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)
Demographics
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03190941 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy.
Does this trial require KRAS?
Yes, KRAS G12V is a required biomarker for enrollment.
Does this trial require NRAS?
Yes, NRAS G12V is a required biomarker for enrollment.
Does this trial require HRAS?
Yes, HRAS G12V is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 72 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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