This study will test a study drug called BPX-601, a CAR-T cell product manufactured from the patient's own T-cells, to see if it can help treat advanced prostate cancer. BPX-601 is a drug that is only used in clinical studies. The study is looking at: * What side effects BPX-601 might cause * What is the best dose of BPX-601 * How well BPX-601 may work to destroy prostate cancer
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Administered per protocol
Emory Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGJohn Theurer Cancer Center
Hackensack, New Jersey, United States
RECRUITINGProvidence Portland Medical Center
Portland, Oregon, United States
RECRUITINGOccurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 4 years
Occurrence of Dose Limiting Toxicities (DLTs)
Time frame: Up to Day 28
Occurrence of Adverse Events of Special Interest (AESIs)
Time frame: Up to 4 years
Objective response
Time frame: Up to 4 years
Duration of Response (DoR)
Time frame: Up to 4 years
Disease control
Time frame: Up to 4 years
≥50% reduction in Prostate-Specific Antigen (PSA50) response
Time frame: Up to 4 years
PSA90 response
Time frame: Up to 4 years
Manufacturing feasibility of BPX-601
Determination of the feasibility of manufacturing BPX-601 is measured by the percent of leukapheresis products collected that are able to be manufactured and released for infusion
Time frame: Up to 4 years
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