SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma

This is a Phase 1, FIH, multicenter, open-label, dose-escalation pilot study of a single

IV gravity drip infusion of SynKIR-110 in subjects with advanced, mesothelin-expressing

tumors (ovarian cancer, primary peritoneal cancer, fallopian tube cancer,

cholangiocarcinoma, or mesothelioma). Up to 42 subjects will be assessed to determine the

safety and feasibility of treatment with SynKIR-110. Informed consent will be obtained

from subjects prior to participation in this study.

The study includes an enrollment screening period (which includes pre-leukapheresis

safety/eligibility and leukapheresis visits), treatment period (administration of

non-myeloablative lymphodepleting chemotherapy followed by a single infusion of

investigational product), and a 12-month follow-up period or until disease progression.

Subjects will be followed for 12 months or until confirmed disease progression, whichever

occurs first, at which point they will be invited to participate in a long-term safety

follow-up study.

Up to 6 cohorts of 3 to 6 subjects per cohort will be treated to determine the safety and

feasibility of treatment with SynKIR-110. Doses will be escalated following a standard 3

+ 3 design until either an MTD or MFD is reached. An additional 6 to 9 subjects will be

treated at the MTD/MFD to further assess safety and potential activity of SynKIR-110.