TCR1020-CD8 T Cells in KRAS-mutated Cancers

Who can take part

• Patients ≥ 18 years of age
• Patients with one of the following diagnoses:; Histologically confirmed metastatic pancreatic adenocarcinoma; Histologically confirmed metastatic colorectal cancer
• HLA-A*11:01 positive
• KRAS G12V mutation positive disease as confirmed by a CLIA certified laboratory
• Received prior treatment for their primary malignancy as follows:; Pancreatic Cancer Patients: At least one prior line of standard of care therapy for advanced stage disease; Colorectal Cancer Patients: At least two prior lines of standard of care therapy for advanced stage disease
• Evidence of active disease within 8 weeks of physician-investigator confirmation of eligibility
• Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as:; Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis; ALT/AST ≤ 5 x ULN (patients with liver metastases) or ALT/AST ≤ 2.5 x ULN (patients without liver metastases); Direct bilirubin ≤ 2 mg/dL, unless the subject has Gilbert's syndrome (if so, direct bilirubin must be ≤3.0 mg/dL); Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO; Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air
• 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:; Hemoglobin ≥ 8 g/dL; Absolute neutrophil count ≥ 1000/μL; Platelet count ≥ 75,000/μL
• ECOG Performance Status that is either 0 or 1
• Signed, written informed consent
• Participants of reproductive potential must agree to use acceptable birth control methods, asdescribed in protocol Section 4.3

Who cannot take part

• 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]
• 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
• Active hepatitis B or hepatitis C infection
• Any other active, uncontrolled infection
• Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 5 of the protocol for full details)
• Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded
• History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40)
• Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study
• Pregnant or nursing (lactating) patients. Participants of reproductive potential must agree to use acceptable birth control methods, as described in protocol Section 4.3