TCR1020-CD8 T Cells in KRAS-mutated Cancers

Inclusion Criteria:

1. Patients ≥ 18 years of age
2. Patients with one of the following diagnoses:

   1. Histologically confirmed metastatic pancreatic adenocarcinoma
   2. Histologically confirmed metastatic colorectal cancer
3. HLA-A\*11:01 positive
4. KRAS G12V mutation positive disease as confirmed by a CLIA certified laboratory.
5. Received prior treatment for their primary malignancy as follows:

   1. Pancreatic Cancer Patients: At least one prior line of standard of care therapy for advanced stage disease
   2. Colorectal Cancer Patients: At least two prior lines of standard of care therapy for advanced stage disease.
6. Evidence of active disease within 8 weeks of physician-investigator confirmation of eligibility.
7. Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:

   1. Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis.
   2. ALT/AST ≤ 5 x ULN (patients with liver metastases) or ALT/AST ≤ 2.5 x ULN (patients without liver metastases)
   3. Direct bilirubin ≤ 2 mg/dL, unless the subject has Gilbert's syndrome (if so, direct bilirubin must be ≤3.0 mg/dL)
   4. Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO
   5. Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
8. Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as:

   1. Hemoglobin ≥ 8 g/dL
   2. Absolute neutrophil count ≥ 1000/μL
   3. Platelet count ≥ 75,000/μL
9. ECOG Performance Status that is either 0 or 1.
10. Signed, written informed consent
11. Participants of reproductive potential must agree to use acceptable birth control methods, asdescribed in protocol Section 4.3.

Exclusion Criteria:

1. Active hepatitis B or hepatitis C infection
2. Any other active, uncontrolled infection.
3. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 5 of the protocol for full details).
4. Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
5. Active invasive cancer, other than the proposed cancer included in the study, within 2 years prior to eligibility confirmation by a physician-investigator. \[Note: non-invasive cancers treated with curative intent (e.g., non-melanoma skin cancer) may still be eligible\].
6. Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3.
7. 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, please see protocol Section 5.6.
8. Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded.
9. History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).