Clinical Trial TitleSafety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors (Prostate or Pancreatic)
National Clinical Trial Number:NCT02744287
Clinical Trial Protocol Description:
BPX-601 is one specific form of CAR-T (chimeric antigen receptor T-cell) therapy. All CAR-T therapies take some of your own immune cells and modify them to better attack your cancer before they are given back to you. BPX-601 differs from previous CAR-T therapies because it is designed to be made more active by a drug rimiducid that is given at least a week after your modified cells. The purpose of this study is to test what dose of the investigational study drugs BPX-601 along with rimiducid can be given safely at various dose levels to participants with certain types of cancer.
The term “investigational” means that it has not been approved by the U.S. Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied.
If you agree to participate in this study, your participation may last up to 5 to 15 years and you will be asked to complete 14 or more study visits (some of which may require short hospitalization).
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have metastatic pancreatic cancer with tumor progression within 6 months of the most recent anti-cancer treatment and documented positive tumor expression of PSCA, and prior treatment with first or second-line therapy.
- Have metastatic castration-resistant prostate cancer (mCRPC), with progressive disease per PCWG3 criteria during or following the direct prior line of therapy.
- Are at least 18 years of age and have a life expectancy > 12 weeks.
You will be excluded from the study if any of the following criteria apply to you:
- Have pancreatic cancer with islet cell neoplasms or symptomatic/untreated coagulopathy.
- Have prostate cancer with unstable bone lesions or symptomatic/untreated coagulopathy, or history of > Grade 2 hematuria within the previous 6 months.
- Have had 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.
- Have known HIV positivity.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.