Prostate Cancer study: BPX-601
Official title A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostate Cancer That Has Returned, is Resistant to Treatment and Has Spread
ClinicalTrials.gov ID: NCT07543055
What this study is testing
What is BPX-601?
BPX-601 is an investigational CAR‑T cell therapy being studied for advanced prostate cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out what side effects BPX‑601 may cause, the best dose, and how well it can destroy prostate cancer cells.
- Who it's for
- Adults with prostate cancer that has returned, is resistant to treatment, and has spread to other parts of the body.
- What's involved
- Participants will receive BPX‑601 made from their own T‑cells. The study will monitor side effects, dose response, and cancer response through medical visits and tests.
- Time commitment
- The study lasts several months, with multiple clinic visits for treatment, monitoring, and follow‑up.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- Histologically or cytologically confirmed diagnosis of hormone-refractory adenocarcinoma of the prostate without pure small cell carcinoma
- Metastatic, Castration-Resistant Prostate Cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening...
- Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting [in addition to Androgen Deprivation...
- Has had either orchiectomy OR is on Luteinizing Hormone-Releasing Hormone (LHRH) agonist or antagonist therapy with serum testosterone \<50 ng/dL AND...
You likely can't join if
- Structurally unstable bone lesions suggesting impending fracture
- Clinical or radiographic evidence of deep vein thrombosis, pulmonary embolism, or other known thromboembolic event that has not been definitively...
- Inadequate renal function defined by creatinine clearance \<60 mL/min calculated by 24-hour urine collection or using the Cockcroft-Gault formula
- Inadequate hepatic function defined by Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) \>2.5 × ULN or \>5 × ULN, if liver...
- Inadequate bone marrow function defined by Absolute Neutrophil Count (ANC) \<1.5 × 10\^9/L or platelet count \<150 × 10\^9/L.
The study team makes the final eligibility decision.
Where it is enrolling
- Atlanta, Georgia, United States
- Hackensack, New Jersey, United States
- Portland, Oregon, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Atlanta, Georgia, United States; Hackensack, New Jersey, United States; Portland, Oregon, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.