Spots Global Cancer Trial Database for P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
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Trial Identification
Brief Title: P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (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)
Study ID: NCT04249947
Conditions
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of California San Diego, San Diego, California, United States
University of California San Francisco, San Francisco, California, United States
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Tulane University Hospital and Clinic, New Orleans, Louisiana, United States
University of Maryland, Baltimore, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States
Contact Details
Name: Rajesh Belani, M.D.
Affiliation: Sponsor Executive Medical Director
Role: STUDY_DIRECTOR
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