TAC T-cells for the Treatment of Claudin 18.2 Positive Solid Tumors (TACTIC-3)

Exclusion Criteria

• •5. Subjects with solid tumors with genetic alterations and mutations (e.g., BRAF, BRCA, EGFR mutations, and ALK translocation) where approved targeted therapies were available to their specific cancers must have been previously treated with such approved therapies, or refused such approved targeted therapy for their cancers, prior to enrollment, or in the opinion of the Investigator would be unlikely to tolerate or derive clinically meaningful benefit from these standard-of-care therapies.
• •6. Measurable disease per RECIST 1.1 at time of enrollment.
• •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening.
• •8. Life expectancy of at least 12 weeks.
• •9. Adequate organ and bone marrow reserve function prior to leukapheresis as outlined in protocol.
• •10. Recovery to Grade ≤ 1 or baseline for any toxicities due to previous therapy, except alopecia, anemia, thrombocytopenia, neutropenia, and neuropathy.
• •1. If a subject received major surgery, they must have recovered from the procedure and/or any complications from the procedure prior to starting TAC01-CLDN18.2 therapy.
• •2. Toxicity that has not recovered to Grade ≤ 1 is allowed if it meets the inclusion requirements for laboratory parameters.
• •11. Adequate vascular access for leukapheresis as per institutional standards
• •12. For women physiologically capable of becoming pregnant, agreement to use highly effective methods of contraception starting 28 days prior to study treatment and continue for 1 year after the last TAC01-CLDN18.2 infusion. For men who have partners physiologically capable of becoming pregnant, agreement to use an effective barrier contraceptive method and refrain from donating sperm during study treatment and for 1 year after the last TAC01-CLDN18.2 infusion.
• •1. Intolerant to any component of TAC01-CLDN18.2
• •2. Prior treatment with any of the following:
• •1. Adoptive cell transfer of any kind, including CAR T cells.
• •2. Gene therapy
• •3. Prior treatment with a CLDN18.2 targeted agent (Phase 2 only)
• •4. Investigational medicinal product within 5 half-lives or 21 days prior to leukapheresis, whichever is shorter.
• •5. Participation in or has participated in a study using an investigational device within 4 weeks prior to the first dose of study treatment.
• •6. Receipt of a live or live-attenuated vaccine within 30 days prior to the first dose of study Intervention. Administration of killed vaccines are allowed.
• •7. Radiation within 28 days prior to leukapheresis. Palliative radiation is allowed up to 14 days prior to leukapheresis if additional non-irradiated lesions are present.
• •8. Chemotherapy or targeted small molecule therapy within 14 days prior to leukapheresis, or within 7 days prior to leukapheresis for erlotinib, gefitinib, afatinib, or crizotinib in NSCLC subjects.
• •9. Colony stimulating factors, including granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, and other hematopoietic cytokines, within 14 days prior to leukapheresis.
• •10. Immunosuppressive medication within 14 days or corticosteroid treatment \< 72 hours prior to leukapheresis, except for physiological replacement doses (\< 12 mg/m2/24 hours of hydrocortisone or equivalent) and topical or inhaled steroids.
• •11. History or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
• •12. Known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study Screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• •13. Active inflammatory neurological disorders (e.g., Guillain-Barre Syndrome, amyotrophic lateral sclerosis, multiple sclerosis).
• •14. Active autoimmune disease (e.g., lupus, rheumatoid arthritis, Sjogren's syndrome) requiring systemic disease modifying agents in the past 2 years. Hormone replacement therapy (e.g., thyroxine, insulin), or physiologic corticosteroid replacement therapy (for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• •15. Active or uncontrolled hepatitis B or C (HCV ribonucleic acid \[RNA\] positive) infection or any history of or active human immunodeficiency virus (HIV) infection.