A PHASE 1 DOSE ESCALATION AND EXPANDED COHORT STUDY OF P-MUC1C-ALLO1 IN ADULT SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS

A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in
adult subjects with advanced or metastatic epithelial derived solid tumors, including but
not limited to the tumor types listed below.

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