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

Inclusion criteria

• ✓. Signed, written informed consent obtained before any study procedures are conducted.
• ✓. Age ≥ 18 years at the time of informed consent.
• ✓. Tumor tissue samples positive for CLDN18.2 as assessed by central laboratory.
• ✓. Histologically confirmed advanced, metastatic, unresectable CLDN18.2+ solid tumors after at least 2 lines of prior therapy (Phase 1) and after at least 2 and no more than 4 prior lines of therapy (Phase 2). Subjects with PDAC may have been treated with 1 line of prior therapy.
• ✓. Subjects with incurable Claudin 18.2 expressing malignancies for which no standard-of-care targeted therapy exists may be enrolled regardless of the number of prior treatment lines.
• ✓. Specific Phase 1 tumor types include gastric, GEJ, esophageal adenocarcinoma, PDAC, colorectal cancer, cholangiocarcinoma, ovarian mucinous cancer, gallbladder cancer and NSCLC.
• ✓. Specific Phase 2 tumor types include gastric and esophageal adenocarcinoma (Group A), PDAC (Group B), and ovarian or NSCLC (Group C). Other tumor types are not eligible.
• ✓. 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.

Exclusion criteria