A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects with Advanced or Metastatic Solid Tumors

Inclusion Criteria:
*  Males or females, Subjects ≥18 years with life expectancy \>3 months
*  Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer
*  Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, and have measurable disease
*  Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%
*  Must have adequate vital organ function within pre-determined parameters
*  Must have archived tumor tissue available or consent to a biopsy collection
*  Must be willing to practice birth control
*  Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration
*  Must have recovered from toxicities due to prior therapies

Exclusion Criteria:
*  Has inadequate venous access
*  Has an active second malignancy (not disease free for at least 5 years) in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
*  Is pregnant or lactating
*  Has a history of or active autoimmune disease
*  Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy
*  Has an active systemic (viral, bacterial, or fungal) infection
*  Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia
*  Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
*  Has received anticancer medications within 2 weeks of the time of initiating lymphodepletion
*  Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study
*  Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study
*  Has known CNS metastases or symptomatic CNS involvement
*  Has a history of significant liver disease or active liver disease
*  Has a history of known genetic predisposition to HLH/MAS
*  Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy