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

Trial Status: Temporarily Closed to Accrual

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

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

California

Duarte
City of Hope Comprehensive Cancer Center
Status: APPROVED
San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

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.

Trial Phase Phase I

Trial Type Treatment

Lead Organization
Poseida Therapeutics, Inc.

  • Primary ID P-PSMA-101-001
  • Secondary IDs NCI-2020-01373
  • Clinicaltrials.gov ID NCT04249947