P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

• Status: Recruiting
• Trial end date: 2036-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poseida Therapeutics, Inc.

Criteria

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 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 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

• Has a history of significant ocular disease

• Has a history of significant liver disease or active liver disease

• Has liver metastases

• Has a history of or known predisposition to HLH or MAS