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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
P-PSMA-101 is an autologous chimeric antigen receptor (CAR) T-cell therapy designed to target prostate cancer cells expressing the cell surface antigen prostate-specific membrane antigen (PSMA).
Rimiducid (safety switch activator) may be administered as indicated
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
Assess the Safety of P-PSMA-101
Incidence and severity of treatment-emergent adverse events
Time frame: Baseline through 15 years
Determine the maximum tolerated dose of P-PSMA-101
Rate of dose limiting toxicities (DLT)
Time frame: Baseline through Day 28
Assess the efficacy of P-PSMA-101 (ORR)
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST), and Prostate Cancer Response assessed by Prostate Cancer Working Group 3 (PCWG3) criteria: Overall Response Rate (ORR)-Percentage of patients with complete response (CR) or partial response (PR).
Time frame: Baseline through 15 years
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