Actively Recruiting
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Led by National Cancer Institute (NCI) · Updated on 2026-04-24
110
Participants Needed
1
Research Sites
562 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 72 years
- Measurable metastatic or unresectable cancer expressing G12V mutated KRAS, NRAS, or HRAS confirmed by approved tests
- Positive for HLA-A*11:01
- Confirmed cancer diagnosis by pathology
- Previously treated with standard systemic therapy for advanced cancer and either non-responsive or recurrent, or declined standard treatment
- Patients with up to 3 asymptomatic brain metastases less than 1 cm or stable after treatment
- ECOG performance status 0 or 1
- Willingness to use birth control during and after treatment (12 months for women, 4 months for men)
- Women of child-bearing potential must agree to pregnancy testing before treatment
- Negative for HIV, hepatitis B antigen, and hepatitis C antibody (with specific testing if positive)
- Adequate blood counts (ANC > 1000/mm^3, WBC ≥ 2500/mm^3, platelets ≥ 80,000/mm^3, hemoglobin > 8.0 g/dL)
- Liver function within limits (ALT/AST ≤ 5x ULN, bilirubin ≤ 2.0 mg/dL or ≤ 3.0 mg/dL for Gilbert's Syndrome)
- Kidney function with eGFR > 60 mL/min or 6-24h creatinine clearance > 60 mL/min
- Completed any prior systemic therapy before enrollment
- Ability to understand and sign informed consent
- Willingness to sign durable power of attorney
- Co-enrollment on protocol 03C0277
You will not qualify if you...
- Large volume pulmonary irradiation
- Pregnant or breastfeeding women of child-bearing potential
- Concurrent systemic steroid therapy
- Active systemic infections requiring treatment
- Coagulation disorders or other major uncompensated medical illnesses
- Primary immunodeficiency disorders
- Opportunistic infections
- Severe allergy or hypersensitivity to cyclophosphamide, fludarabine, or aldesleukin
- History of coronary revascularization or ischemic heart symptoms
- Left ventricular ejection fraction ≤ 45% if clinically indicated
- Forced expiratory volume (FEV1) ≤ 50% or diffusing capacity (DLCO) ≤ 60% if clinically indicated
- Receiving other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
N
NCI SB Immunotherapy Recruitment Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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