A Phase 2, Single-Center, Open Label Study of Autologous, Adoptive Cell Therapy Following a Reduced Intensity, Non-myeloablative, Lymphodepleting Induction Regimen in Metastatic Urothelial Carcinoma Patients

Inclusion Criteria

• •1. Histologically confirmed Urothelial Carcinoma
• •2. Progressed on first line platinum-based chemotherapy and on second line immunotherapy or targeted therapy (FGFR inhibitor)
• •3. Measurable metastatic Urothelial Carcinoma with at least one lesion that is resectable for TIL generation.
• •4. Patients with one or more brain metastases less than 1 cm each, and any patients with 1 or 2 brain metastases greater than 1 cm must have been treated and stable for 4 weeks.
• •5. Greater than or equal to 18 years of age.
• •6. Willing to practice birth control from the start of chemotherapy until 120 days after release from the hospital.
• •7. Life expectancy of greater than three months
• •8. Willing to sign a durable power of attorney
• •9. Able to understand and sign the Informed Consent Document
• •10. Clinical performance status of ECOG 0 or 1
• •11. Hematology:
• •* Absolute neutrophil count greater than 1000/mm3 without support of filgrastim
• •* Normal WBC ( \> 3000/mm3).
• •* Hemoglobin greater than 8.0 g/dL
• •* Platelet count greater than 100,000/mm3
• •12. Serology:
• •* Seronegative for HIV antibody. (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive can have decreased immune competence and thus can be less responsive to the experimental treatment and more susceptible to its toxicities.)
• •* Seronegative for Hepatitis B or Hepatitis C. (patients who recovered from previous infection and have no detected HBSAg or HCV RNA are allowed).
• •13. Chemistry:
• •* Serum ALT/AST less than three times the upper limit of normal (ULN).
• •* Serum creatinine less than or equal to 1.6 mg/dL
• •* Total bilirubin no more than x1.5 times the ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin less than 3 mg/dL.
• •14. Negative pregnancy test in women of child bearing potential because of the potentially dangerous effects of the preparative chemotherapy on the fetus.
• •15. More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a grade 1 or less (except for toxicities such as alopecia or vitiligo). Patients may have undergone minor surgical procedures with the past 3 weeks, as long as all toxicities have recovered to grade 1 or less.