The purpose of this study is to evaluate the safety and activity of BPX-601 CAR-T cells in participants with previously treated advanced solid tumors (prostate) expressing high levels of prostate stem cell antigen (PSCA). Participants' T cells are modified to recognize and target the PSCA tumor marker on cancer cells.
Former Sponsor Bellicum Pharmaceuticals Study ended prior to the start of Phase 2
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain
Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence
Moffitt Cancer Center
Tampa, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Dose Limiting Toxicity
Incidence of dose limiting toxicity
Time frame: 4 weeks after first rimiducid infusion (i.e., Day 35)
Treatment emergent adverse events (AEs) and serious AEs (SAEs)
Number of participants with adverse events (AEs) and serious AEs (SAEs) assessed for severity using NCI CTCAE v4.03
Time frame: 180 days after BPX-601 treatment up to 15 years
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Identify the optimal dose of BPX-601 with rimiducid for Phase 2
Time frame: through Phase 1 completion, up to 5 years
Pharmacodynamics (PD) of BPX-601
Change from baseline in pharmacodynamic blood biomarkers - markers of BPX-601 CAR-T cells
Time frame: up to 1 year after treatment
Antitumor activity of BPX-601
Percentage of subjects with objective response determined by the investigator according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or the Prostate Cancer Working Group 3 (PCWG3) criteria
Time frame: From the time of BPX-601 cell infusion until confirmed disease progression or death due to any cause, the start of new anticancer therapy, or withdrawal, whichever comes first, as assessed for up to 5 years after the last subject has been enrolled
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University of Chicago Medicine
Chicago, Illinois, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
University of Nebraska
Omaha, Nebraska, United States
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
...and 3 more locations