Engineered immune cells take aim at Hard-to-Treat prostate cancer
NCT ID NCT02744287
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a new treatment called BPX-601 for people with advanced prostate cancer that had stopped responding to other therapies. The treatment uses a patient's own immune cells, modified to recognize and attack cancer cells carrying a specific marker (PSCA). The main goals were to check safety and find the right dose. The study was terminated early, but results help guide future research.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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52 people
The number who actually took part.
- Started
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Nov 2016
- Finished
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Mar 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy. * Measurable disease per RECIST v1.1 at baseline; subjects with mCRPC with bone only metastases must have measurable PSA. * Age ≥18 years. * Life expectancy \> 12 weeks. * ECOG 0-1 * Adequate organ function. Exclusion Criteria: * Prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of \> Grade 2 hematuria within the previous 6 months. * Prior CAR T cell or other genetically-modified T cell therapy. Prior treatment with an immune-based therapy for the treatment of prostate cancer, including cancer vaccine therapies are allowable. * Symptomatic, untreated, or actively progressing central nervous system metastases. * Impaired cardiac function or clinically significant cardiac disease. * Pregnant or breastfeeding. * Participant requires chronic, systemic steroid therapy. * Severe intercurrent infection. * Known HIV positivity.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baylor Sammons Cancer Center
Dallas, Texas, 75246, United States
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Columbia University Medical Center
New York, New York, 10032, United States
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Duke University
Durham, North Carolina, 27705, United States
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Emory Winship Cancer Institute
Atlanta, Georgia, 30322, United States
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John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
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University of Chicago Medicine
Chicago, Illinois, 60637, United States
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University of Nebraska
Omaha, Nebraska, 68198, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First-in-Human biologic JUR-003 put to the test against metastatic prostate cancer
- New drug combo targets CD46 in aggressive prostate cancer
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a Hormone-Blocking drug boost chemotherapy against prostate cancer?
- Two-Drug combo targets prostate cancer that outsmarts hormone therapy
- AI chatbot may calm nerves after a prostate cancer diagnosis