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, refractory to standard of care therapy or ineligible or refused other existing treatment options
• Must have progressed during or after last therapy 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 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 conditioning chemotherapy
• 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