Overview
An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC.
Description
This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D.
Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.
Eligibility
Inclusion Criteria:
- Males 18 years of age
- Must have a confirmed diagnosis of mCRPC
- Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (1 ng/mL)
- Must have progressed by PCWG3 and/or RECIST 1.1
- 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, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
- Has active autoimmune disease
- Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
- Has an active systemic infection
- Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks or 5 half-lives (whichever is longer) 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