Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD UCSF
Dates
study started
estimated completion

Description

Summary

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.

Official Title

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)

Details

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.

Keywords

Prostatic Neoplasms, Castration-Resistant Neoplasms by Histologic Type Neoplasms, Prostate Prostate Cancer Metastatic Castration-resistant Prostate Cancer Neoplasms Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Prostatic Disease Salivary Gland Cancer Salivary Gland Tumor Adenoid Cystic Carcinoma Salivary Duct Carcinoma Mucoepidermoid Carcinoma Acinic Cell Tumor CAR-T cells metastatic castration-resistant prostate cancer (mCRPC) Carcinoma Salivary Gland Neoplasms Carcinoma, Adenoid Cystic Carcinoma, Mucoepidermoid Mucoepidermoid Tumor Carcinoma, Acinar Cell Prostatic Diseases P-PSMA-101 CAR-T cells Rimiducid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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 </= 2.5 cm permitted)
  • Has a history of or known predisposition to HLH or MAS

Locations

  • University of California San Diego accepting new patients
    San Diego California 92093 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Poseida Therapeutics, Inc.
ID
NCT04249947
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated