Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanc… (NCT02744287) | Clinical Trial Compass
TerminatedPhase 1
Safety and Activity Study of PSCA-Targeted CAR-T Cells (BPX-601) in Subjects With Selected Advanced Solid Tumors
Stopped: Due to a Dose Limiting Toxicity.
United States52 participantsStarted 2016-11-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity
Timeframe: 4 weeks after first rimiducid infusion (i.e., Day 35)
2
Treatment emergent adverse events (AEs) and serious AEs (SAEs)
Timeframe: 180 days after BPX-601 treatment up to 15 years
3
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Timeframe: through Phase 1 completion, up to 5 years