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)

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.

 

Sponsor

Poseida Therapeutics

Status of enrollment

Active, not accepting new patients

Ages Eligible for Study

Adults ages 18 and up

Genders Eligible for Study

Males and Females

Disease indication

Prostate Cancer, Salivary Gland Cancer

 

Principal Investigator

David Oh, MD, PhD

Contact

Marissa Gin

[email protected]

 

Additional study eligibility details can be found at UCSF Clinical Trials.