This is a single center, single arm Phase I study to establish the safety and feasibility of intravenously administered lentivirally transduced dual PSMA-specific/TGFβ-resistant CAR modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate resistant prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
autologous CAR T cells
300 mg/m2/day given over 3 days
30 mg/m2/day given over 3 days
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.
using CTCAE v 4.03
Time frame: 15 years
Clinical feasibility is defined as the frequency of subjects enrolled on this protocol who do not receive CART-PSMA-TGFβRDN cells.
Time frame: 30 days
Manufacturing feasibility is determined by the frequency of product release failures and the occurrence of dose failures (inability to meet target dose).
Time frame: 30 days
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by RECIST
RECIST 1.1 criteria for soft tissue disease
Time frame: 6 months
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by PCWG2
PCWG2 criteria for osseous disease
Time frame: 6 months
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by serum PSA measurement
serum PSA measurement
Time frame: 6 months
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by overal survival (OS).
Time frame: 15 Years
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by number of subjects with progression free survival (PFS).
Time frame: 15 Years
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