P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

Inclusion Criteria:

Subjects ≥18 years of age
Must have a confirmed diagnosis of mCRPC or SGC
Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL) (mCRPC subjects only)
Must have progressed by PCWG3 and/or RECIST 1.1 (mCRPC subjects only)
Must be willing to practice birth control from screening and for 2 years after the last administration of P-PSMA-101
Must have adequate vital organ function within pre-determined parameters
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria:

Has inadequate venous access and/or contraindications to leukapheresis
Has an active second malignancy in addition to mCRPC or SGC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
Has a history of or active autoimmune disease
Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
Has an active systemic (viral, bacterial or fungal) infection
Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks of the time of initiating conditioning chemotherapy
Has received immunosuppressive medications (including anti-cancer medications) within 2 weeks of initiating leukapheresis and/or expected to require them while enrolled in the study
Has received systemic corticosteroid therapy within 2 weeks of either the required leukapheresis or is expected to require it during the course of the study
Has CNS metastases or symptomatic CNS involvement
Has a history of significant ocular disease
Has a history of significant liver disease or active liver disease
Has liver metastases (<5 lesions and maximum diameter Has a history of or known predisposition to HLH or MAS