Genetically Engineered Cells (TCR1188-ABC) for the Treatment of Metastatic Pancreatic Cancer, Cholangiocarcinoma, Colorectal Cancer, or Non-Small Cell Lung Cancer

Inclusion Criteria

• Patients >= 18 years of age
• Patients with one of the following diagnoses: * Histologically confirmed metastatic pancreatic adenocarcinoma or cholangiocarcinoma * Histologically confirmed metastatic colorectal cancer * Histologically confirmed metastatic non-small cell lung cancer
• HLA-A*11:01 positive as confirmed by a Clinical Laboratory Improvement Act (CLIA) certified laboratory
• KRAS G12V mutation positive disease as confirmed on tissue, blood, or plasma by next generation sequencing by a CLIA certified laboratory
• Received prior treatment for their primary malignancy as follows: * Pancreatic cancer/cholangiocarcinoma patients: At least one prior line of standard of care therapy for advanced stage disease. For pancreatic cancer patients, this must include a gemcitabine or fluorouracil (5 FU)-based regimen * Colorectal cancer patients: At least three prior lines of standard of care therapy for advanced stage disease. Prior treatment must include all of the following unless the patient was ineligible for a specific therapy type: i). a fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimen, ii). an anti-vascular endothelial growth factor (VEGF) agent, and iii). regorafenib, trifluridine-tipiracil, or fruquintinib. Patients with microsatellite instability-high (MSI-H) disease must also have received, or be ineligible for, prior treatment with an immune checkpoint inhibitor * Non-small cell lung cancer patients: At least one prior line of standard of care therapy for advanced stage disease
• Evidence of radiographically detectable disease within 8 weeks of physician-investigator confirmation of eligibility
• Serum creatinine =< 1.5 mg/dl or creatinine clearance >= 50 cc/min per the Cockcroft-Gault equation; patient must not be on dialysis (within 4 weeks of eligibility confirmation)
• Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 5 x upper limit of normal (ULN) (patients with liver metastases) or ALT/AST =< 2.5 x ULN (patients without liver metastases) (within 4 weeks of eligibility confirmation)
• Total bilirubin =< 1.5 mg/dL x ULN, unless the subject has Gilbert's syndrome (if so, direct bilirubin must be =< 2.0 mg/dL x ULN) (within 4 weeks of eligibility confirmation)
• Left ventricle ejection fraction (LVEF) >= 50% confirmed by ECHO/MUGA (within 4 weeks of eligibility confirmation)
• Must have a minimum level of pulmonary reserve defined as =< grade 1 dyspnea and pulse oxygen > 92% on room air (within 4 weeks of eligibility confirmation)
• Hemoglobin >= 8 g/dL (within 4 weeks of eligibility confirmation) * Must not be dependent on transfusions to maintain these hematologic parameters
• Absolute neutrophil count >= 1000/uL (within 4 weeks of eligibility confirmation) * Must not be dependent on transfusions to maintain these hematologic parameters
• Platelet count >= 100,000/uL (within 4 weeks of eligibility confirmation) * Must not be dependent on transfusions to maintain these hematologic parameters
• Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1
• Signed, written informed consent

Exclusion Criteria

• Active hepatitis B or hepatitis C infection
• Patients with a severe acquired or inherited immunodeficiency, including HIV positive patients with a CD4 count =< 350 cells/uL. In order to qualify, HIV positive patients must also be on an established antiretroviral therapy regimen with a viral load of < 400 copies/mL
• Any other active, uncontrolled infection
• Class III/IV cardiovascular disability according to the New York Heart Association Classification
• Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study
• Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. (Note: non-invasive cancers treated with curative intent [e.g., non-melanoma skin cancer] may still be eligible)
• Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods, as described
• Patients requiring chronic treatment with systemic steroids or immunosuppressant medications. Low-dose physiologic replacement therapy with corticosteroids equivalent to prednisone 10 mg/day or lower, topical steroids and inhaled steroids are acceptable. For additional details regarding use of steroid and immunosuppressant medications
• Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to >= 10mg daily of prednisone. Patients with autoimmune neurologic diseases (such as multiple sclerosis [MS]) will be excluded
• Patients with unstable angina, serious uncontrolled cardiac arrhythmia, and/or myocardial infarction within 6 months of physician-investigator confirmation of eligibility
• Prior history of myocarditis
• Patients with pneumonitis/interstitial lung disease requiring steroid treatment
• Patients with active/untreated brain metastases. (Note: History of treated metastases may still be eligible)
• History of allergy or hypersensitivity to study product excipients (human serum albumin, dimethyl sulfoxide [DMSO], and Dextran 40) or tocilizumab