A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
Trial Description
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous
CAR-T cells in patients with mCRPC and SGC.
Eligibility Requirements
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